PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, sho
FDA device recall Z-0960-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- The product was breaking during use.
- Action taken
- All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 159 units
- Distribution
- Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress
- Date initiated
- 2008-11-21
- Date posted
- 2009-02-03
- Date terminated
- 2012-11-27
- Location
- Memphis, TN
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, INC., PROMOS REVERSE SHOULDER SYSTEM (K081016) | Smith & Nephew, Inc. | 2008-09-05 |