Recall Z-2027-2009 ยท JDW Pin, Fixation, Threaded
Smith & Nephew Inc
Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, for external fixation of finger joint.
| Date | Sep 15, 2009 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | Hinge failure: The product is cracking or breaking during use. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 7,089 units |
| Distribution | Worldwide Distribution: USA, Turkey, Denmark, Germany, Malaysia, Hong Kong, Korea, Switzerland, Japan, Singapore, Canada, New Zealand, Australia, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994143 | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] Smith & Nephew, Inc., Feb 18, 2000 |