Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Ar
FDA device recall Z-2646-2011 · posted 2011-06-24 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)
- Action taken
- Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810. Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 11 units
- Distribution
- Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.
- Date initiated
- 2011-05-19
- Date posted
- 2011-06-24
- Date terminated
- 2012-05-09
- 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 |
|---|---|---|
| SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY (K102544) | Smith & Nephew Inc., Endoscopy Div. | 2011-01-05 |