ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
FDA device recall Z-1822-2015 · posted 2015-06-22 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- Sterility of device maybe compromised
- Action taken
- Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GAT
- Quantity affected
- 202,279 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa
- Date initiated
- 2015-04-30
- Date posted
- 2015-06-22
- Date terminated
- 2017-09-19
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TFCC FAST-FIX KIT (K132079) | Smith & Nephew, Inc. | 2013-12-05 |