Guide, Surgical, Instrument
FDA product code FZX · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
19510(k) clearances
0PMA approvals
29recalls
Manufacturers
- Biosearch Medical Products, Inc. 2
- Acufex Microsurgical, Inc. 2
- Plastafil, Inc. 2
- Howmedica Corp. 1
- The Urology Group 1
- The Buckeye Cellulose Corp. 1
- Medcare Products 1
- Surgical Technology Laboratories, Inc. 1
- Techmedica, Inc. 1
- Downs Surgical , Ltd. 1
- North American Instrument Corp. 1
- Meadox Surgimed, Inc. 1
- Aspen Laboratories, Inc. 1
- Amedic USA 1
- CIVCO Medical Instruments Co., Inc. 1
- Implant Corp. of America 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914715 | Paralleling GuidesFZX · Traditional | Implant Corp. of America | 02/16/1994SE |
| K871413 | Civco StepperFZX · Traditional | CIVCO Medical Instruments Co., Inc. | 07/14/1987SE |
| K871503 | Biopsy Needle Guide Kit, SterileFZX · Traditional | Amedic USA | 07/10/1987SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | Aspen Laboratories, Inc. | 08/18/1986SE |
| K854262 | Meadox Surgimed Breast Localization Wire Set/OnlyFZX · Traditional | Meadox Surgimed, Inc. | 12/24/1985SE |
| K852402 | Namic Homer Mammalok Needle/Wire LocalizerFZX · Traditional | North American Instrument Corp. | 07/11/1985SE |
| K842698 | British Spinal Fusion SetFZX · Traditional | Downs Surgical , Ltd. | 09/12/1984SE |
| K841618 | Threading TubeFZX · Traditional | Plastafil, Inc. | 08/27/1984SE |
| K841619 | Drill GuideFZX · Traditional | Plastafil, Inc. | 07/11/1984SE |
| K841297 | Techmedica Drill GuideFZX · Traditional | Techmedica, Inc. | 04/25/1984SE |
| K840835 | Straith Drain InserterFZX · Traditional | Surgical Technology Laboratories, Inc. | 04/23/1984SE |
| K834350 | Acufex Drez Communicating Drill GuideFZX · Traditional | Acufex Microsurgical, Inc. | 03/19/1984SE |
| K830720 | Graf Meniscal Suture SetFZX · Traditional | Acufex Microsurgical, Inc. | 06/16/1983SE |
| K821618 | Disposable Needle HoldersFZX · Traditional | Medcare Products | 06/21/1982SE |
| K810888 | Boundary Tubing HoldersFZX · Traditional | The Buckeye Cellulose Corp. | 04/23/1981SE |
| K810788 | Surgical Tube HolderFZX · Traditional | The Urology Group | 04/17/1981SE |
| K802093 | Gabbay-Frater Suture GuideFZX · Traditional | Howmedica Corp. | 09/26/1980SE |
| K792468 | Feeding Tube Placement StyletFZX · Traditional | Biosearch Medical Products, Inc. | 12/27/1979SE |
| K790872 | Enteric Tube GuideFZX · Traditional | Biosearch Medical Products, Inc. | 05/23/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0749-2024 Class II | Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System…Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due… | Waldemar Link GmbH & Co. KG (Mfg Site) | 11/30/2023Open, Classified |
| Z-0669-2025 Class II | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical…IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set | Hologic, Inc | 10/10/2022Completed |
| Z-0531-2020 Class II | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-0530-2020 Class II | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-0529-2020 Class II | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-1472-2018 Class II | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length…Potential failure of sterile packaging seal. | Zimmer Biomet, Inc. | 03/26/2018Terminated |
| Z-0669-2018 Class II | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini…May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the… | Synthes, Inc. | 08/07/2017Terminated |
| Z-2538-2017 Class II | Endoscopic Introducer/Extractorreprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and… | Cook Inc. | 04/25/2017Terminated |
| Z-0083-2017 Class II | Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and…Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable… | Zimmer Biomet, Inc. | 08/09/2016Terminated |
| Z-2214-2016 Class II | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide…DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part #… | Synthes (USA) Products LLC | 06/07/2016Terminated |
| Z-1815-2016 Class II | Various trauma and sports medicine instruments and implants. guide, surgical, instrumentInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | Biomet, Inc. | 04/01/2016Terminated |
| Z-1312-2016 Class II | Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical…DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which… | Synthes (USA) Products LLC | 02/16/2016Terminated |
| Z-2820-2015 Class II | Zimmer Guide Wires for orthopedic procedures.Product labeling of these sterile guide wires (external carton label and patient record label) states a… | Zimmer, Inc. | 08/27/2015Terminated |
| Z-2455-2015 Class II | Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The…The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the… | Omnilife Science Inc. | 06/09/2015Terminated |
| Z-2454-2015 Class II | Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The…The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the… | Omnilife Science Inc. | 06/09/2015Terminated |
| Z-1799-2015 Class II | Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with…Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect… | Synthes, Inc. | 05/28/2015Terminated |
| Z-1819-2015 Class II | ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are…There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the… | Orthofix, Inc | 05/11/2015Terminated |
| Z-1281-2015 Class II | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX…For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the… | Synthes, Inc. | 02/17/2015Terminated |
| Z-2136-2014 Class II | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex…Revision B of the tissue shields of the device was 7 mm longer than the previous design. | X Spine Systems Inc | 07/11/2014Terminated |
| Z-0992-2014 Class II | Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial…One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead… | Synthes, Inc. | 01/27/2014Terminated |
| Z-0460-2014 Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | Zimmer, Inc. | 11/19/2013Terminated |
| Z-0459-2014 Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non…This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments… | Zimmer, Inc. | 11/19/2013Terminated |
| Z-0589-2014 Class II | ITST THREADED GUIDE PINBased on a review of historic packaging validations, it was determined that a subset of product packaged at… | Zimmer, Inc. | 11/05/2013Terminated |
| Z-0381-2014 Class II | REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless…Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance… | Biomet, Inc. | 10/25/2013Terminated |
| Z-1871-2013 Class II | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse…Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a… | SpineFrontier, Inc. | 11/09/2012Terminated |
| Z-2381-2012 Class II | The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to…Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during… | Integra Life Sci. | 06/14/2012Terminated |
| Z-0076-2012 | MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST…Biomet has initiated this action following an investigation which identified that the blueprint calls for… | Biomet, Inc. | 09/16/2011Terminated |
| Z-1833-2011 | REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY:…Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being… | Biomet, Inc. | 02/10/2011Terminated |
| Z-0367-2010 | Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless…Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a… | Biomet, Inc. | 08/06/2009Terminated |