Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of fing
FDA device recall Z-2027-2009 · posted 2009-09-15 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Hinge failure: The product is cracking or breaking during use.
- Action taken
- The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JDW
- Quantity affected
- 7,089 units
- Distribution
- Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy.
- Date initiated
- 2009-01-23
- Date posted
- 2009-09-15
- Date terminated
- 2013-07-29
- 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 EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] (K994143) | Smith & Nephew, Inc. | 2000-02-18 |