Accessories, Arthroscopic
FDA product code NBH · Class I (low risk) · 21 CFR 888.1100 · Orthopedic
2510(k) clearances
0PMA approvals
55recalls
Manufacturers
510(k) clearances
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0301-2021 Class II | 5.5MM Arthrogarde Hip Access CannulaThe J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking… | Smith & Nephew, Inc. | 09/21/2020Terminated |
| Z-2259-2019 Class II | K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2258-2019 Class II | Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2257-2019 Class II | Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2256-2019 Class II | Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2255-2019 Class II | Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2254-2019 Class II | Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2253-2019 Class II | Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2252-2019 Class II | Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2251-2019 Class II | Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2250-2019 Class II | Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2249-2019 Class II | Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2248-2019 Class II | Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2247-2019 Class II | Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2246-2019 Class II | Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2245-2019 Class II | K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2244-2019 Class II | K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2243-2019 Class II | K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2242-2019 Class II | K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2241-2019 Class II | K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2240-2019 Class II | K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2239-2019 Class II | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez…Manufacturing flaw in the sterile barrier system | BioPro, Inc. | 06/25/2019Terminated |
| Z-2945-2018 Class II | Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001.…Possible nonconforming blades may result in a higher than specified cut force required to cut the suture. | Ceterix Orthopedics, Inc. | 05/16/2018Terminated |
| Z-2218-2016 Class II | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for…The device could be subject to breaches of its sterile packaging. | Smith & Nephew, Inc. | 06/15/2016Terminated |
| Z-1910-2016 Class II | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is…Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in… | Stryker Corporation | 05/04/2016Terminated |
| Z-0793-2016 Class II | Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument…Blade exhibiting fracture during hip arthroscopy procedures | Smith & Nephew, Inc. | 01/11/2016Terminated |
| Z-0250-2016 Class II | NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery:…The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture… | Ceterix Orthopedics, Inc. | 10/13/2015Terminated |
| Z-0818-2016 Class II | High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are…During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender… | Smith & Nephew, Inc., Endoscopy Div. | 07/30/2013Terminated |
| Z-1641-2013 Class II | - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref.…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-1278-2013 Class II | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy…Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. | DePuy Mitek, Inc., a Johnson & Johnson Co. | 04/15/2013Terminated |
| Z-0700-2016 Class II | Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic…Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw… | Smith & Nephew, Inc., Endoscopy Div. | 04/04/2013Terminated |
| Z-0922-2013 Class II | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended…Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be… | Instratek, Incorporated | 09/18/2012Terminated |
| Z-1226-2012 | Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1)…The firm received several complaints from customers reporting that the blade of the EGR system may not… | Integra LifeSciences Corp. | 01/06/2012Terminated |
| Z-0048-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Green) Catalog Number: 72201716F…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0047-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0046-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Purple) Catalog Number: 72201714F…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0045-2011 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713F…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0044-2011 | Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0043-2011 | Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0042-2011 | Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0041-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0040-2011 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX…Endofemoral Aimer tip may separate due to failure of the soldered joint | Smith & Nephew, Inc. Endoscopy Division | 04/29/2010Terminated |
| Z-0656-2010 | Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff…Device failed to deploy the distal loop | TAG Medical Corp. | 12/04/2009Terminated |
| Z-0417-2010 | AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic…Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | Smith & Nephew, Inc., Endoscopy Div. | 09/03/2009Terminated |
| Z-0416-2010 | AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic…Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | Smith & Nephew, Inc., Endoscopy Div. | 09/03/2009Terminated |
| Z-0415-2010 | AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic…Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm. | Smith & Nephew, Inc., Endoscopy Div. | 09/03/2009Terminated |
| Z-1567-2009 | Smith & Nephew Endoscopic Disposable Blades:TURBOWHISKER BLD,EP-1,4.5MM(6) Part #:…Product sterility is compromised due to breach in the sterile packaging. | Smith & Nephew, Inc. Endoscopy Division | 05/07/2009Terminated |
| Z-1566-2009 | Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #:…Product sterility is compromised due to breach in the sterile packaging. | Smith & Nephew, Inc. Endoscopy Division | 05/07/2009Terminated |
| Z-1565-2009 | Smith & Nephew Endoscopic Disposable Blades: BOXED F/R,BL,4.5MM,SERIES 3000 /6 Product…Product sterility is compromised due to breach in the sterile packaging. | Smith & Nephew, Inc. Endoscopy Division | 05/07/2009Terminated |
| Z-1564-2009 | Smith & Nephew Endoscopic Disposable Blades: DISPOSABLE BL,4.5MM FR ELITE Part #:…Product sterility is compromised due to breach in the sterile packaging. | Smith & Nephew, Inc. Endoscopy Division | 05/07/2009Terminated |