Biomet Microfixation, Inc.
Medical device manufacturer in Jacksonville, FL.
30510(k) clearances
1PMA approvals
62recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261002 | Pectus Blu SystemHRS · Traditional | 06/02/2026SE |
| K241709 | Pectus Blu Support Bar SystemHRS · Traditional | 09/19/2024SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | 11/15/2022SE |
| K212782 | SternaLock Sternal Closure SystemHRS · Traditional | 05/17/2022SE |
| K212608 | RibFix Blu Thoracic Fixation SystemHRS · Traditional | 04/22/2022SE |
| K213712 | Pectus Support Bar SystemHRS · Traditional | 03/11/2022SE |
| K213208 | Twist DrillsHBE · Traditional | 12/23/2021SE |
| K202969 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | 08/05/2021SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | 06/05/2019SE |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemHRS · Special | 12/09/2016SE |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure SystemHRS · Special | 11/23/2016SE |
| K161896 | Biomet Microfixation Sternal Closure SystemHRS · Special | 08/02/2016SE |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemHRS · Traditional | 03/24/2016SE |
| K152326 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | 12/10/2015SE |
| K151019 | SternaLock® 360 Sternal Closure SystemHRS · Traditional | 11/03/2015SE |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemHWC · Special | 05/26/2015SE |
| K143336 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | 04/01/2015SE |
| K142823 | Biomet Microfixation Thoracic Fixation SystemHRS · Traditional | 02/25/2015SE |
| K132600 | Facial Prebent Plating with Virtual Surgical PlanningJEY · Special | 10/02/2013SE |
| K131674 | Prebent Plating with Virtual Surgical PlanningJEY · Special | 08/08/2013SE |
| K130309 | Rapidflap LS Cranial Flap Fixation SystemGXR · Traditional | 06/17/2013SE |
| K121624 | Biomet Microfixation Neuro Plating SystemGWO · Traditional | 10/12/2012SE |
| K121589 | Biomet Microfixation Facial Plating SystemJEY · Special | 09/21/2012SE |
| K121302 | Biomet Microfixation Sternal Closure SystemHRS · Special | 09/19/2012SE |
| K113512 | Biomet Microfixation Mandibular Fracture/ Reconstruction Devices and Prebent Plates SystemJEY · Special | 06/29/2012SE |
| K111908 | Biomet Microfixation Sternal Closure SystemHWC · Traditional | 11/29/2011SE |
| K110574 | Biomet Microfixation Sternalock Blu Sternal Closure SystemHRS · Special | 05/18/2011SE |
| K091058 | Adkins StrutHRS · Traditional | 07/22/2009SE |
| K081067 | Fracture/Reconstruction System (Traumaone)JEY · Special | 05/09/2008SE |
| K071577 | Biomet Microfixation Lactosorb Pectus StabilizerHRS · Traditional | 09/06/2007SE |
PMA approvals
- P020016 Walter Lorenz Total Temporomandibular Joint Replacement System · 09/21/2005 · 11 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2073-2017 Class II | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600Part of the number on the tray lid differ from the part number on the base. | 04/11/2017Terminated |
| Z-2751-2016 Class II | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom…Potential sterility deficiency. | 06/13/2016Terminated |
| Z-0137-2016 Class II | Thinflap System Case The cases hold surgical instrumentation in place during handling…The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without… | 08/06/2015Terminated |
| Z-0136-2016 Class II | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling…The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without… | 08/06/2015Terminated |
| Z-0522-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0521-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0520-2015 Class II | Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0519-2015 Class II | Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0518-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0517-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0516-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0515-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0514-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0513-2015 Class II | Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0512-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0511-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0510-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand…Laser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-0509-2015 Class II | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti MandLaser etching on the parts is wider and deeper than the conditions previously validated. | 10/17/2014Terminated |
| Z-2566-2014 Class II | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part#…Product mix occurred prior to final package and labeling process. | 09/20/2013Terminated |
| Z-0843-2012 | The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and…Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model… | 11/23/2011Terminated |
| Z-1323-2012 | The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device.…On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring… | 11/15/2011Terminated |
| Z-0012-2012 | Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX…On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850… | 08/18/2011Terminated |
| Z-0447-2012 | Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L)…Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure… | 07/08/2011Terminated |
| Z-0836-2012 | Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM…On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504… | 11/08/2010Terminated |
| Z-0835-2012 | Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM…On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504… | 11/08/2010Terminated |
| Z-2852-2011 | "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT…Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ… | 10/08/2010Terminated |
| Z-2851-2011 | "***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE…Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ… | 10/08/2010Terminated |
| Z-2850-2011 | "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE…Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ… | 10/08/2010Terminated |
| Z-2849-2011 | "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE…Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ… | 10/08/2010Terminated |
| Z-0108-2011 | 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. )…Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long… | 08/31/2010Terminated |
| Z-2385-2011 | ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218…Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120… | 07/28/2010Terminated |
| Z-2779-2011 | Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT…Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5… | 06/25/2010Terminated |
| Z-2392-2010 | BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS…The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used. | 06/25/2010Terminated |
| Z-2873-2011 | "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159")…On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self… | 05/17/2010Terminated |
| Z-1286-2012 | Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE…On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left… | 04/26/2010Terminated |
| Z-0823-2012 | The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular…Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part #… | 04/07/2010Terminated |
| Z-0822-2012 | The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint…Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part #… | 04/07/2010Terminated |
| Z-2206-2010 | BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM…Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in… | 03/17/2010Terminated |
| Z-2913-2011 | "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER…Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot #… | 03/15/2010Terminated |
| Z-1319-2010 | BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS…The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction… | 01/15/2010Terminated |
| Z-0538-2010 | Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH…The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged… | 11/06/2009Terminated |
| Z-1151-2010 | BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER…Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile… | 10/06/2009Terminated |
| Z-1943-2010 | BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM…Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may… | 10/05/2009Terminated |
| Z-0490-2010 | LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185…Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350… | 09/15/2009Terminated |
| Z-0489-2010 | LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT…Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350… | 09/15/2009Terminated |
| Z-1323-2009 | Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by :…This recall is based on the occurrence of known adverse effects identified in the device instructions for… | 03/20/2009Terminated |
| Z-0169-2010 | Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows:…Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly… | 02/19/2009Terminated |
| Z-1949-2009 | BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP…Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450… | 02/16/2009Terminated |
| Z-0534-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD…Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and… | 01/09/2009Terminated |
| Z-0533-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD…Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and… | 01/09/2009Terminated |
| Z-0532-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD…Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and… | 01/09/2009Terminated |
| Z-0531-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD…Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and… | 01/09/2009Terminated |
| Z-0530-2010 | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD…Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and… | 01/09/2009Terminated |
| Z-0415-2009 | Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor…Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. | 10/24/2008Terminated |
| Z-0867-2009 | REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9")…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0866-2009 | REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C.…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0865-2009 | REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0864-2009 | REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25")…Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small… | 08/06/2008Terminated |
| Z-0282-2009 | HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization…The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM… | 07/11/2008Terminated |
| Z-0906-2009 | Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL…The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part… | 05/21/2008Terminated |
| Z-1871-2008 | Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and…The working tips of the Stella Osteotomes are thicker than specification. | 04/16/2008Terminated |
| Z-1872-2008 | Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810…The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as… | 03/19/2008Terminated |