Recall Z-1194-2007 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer Inc.
Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
| Date | Aug 23, 2007 (initiated Jun 25, 2007) |
| Status | Terminated |
| Reason | The package actually contains a knee patellar implant. |
| Root cause | Other |
| Action | The firm notifed the distributor via letter dated 6/25/07, and sent by email, to retrieve the product from their customers and to return the product. |
| Quantity | 10 |
| Distribution | Maryland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990136 | ANATOMICA GLENOID COMPONENT Sulzer Orthopedics, Inc., Mar 1, 1999 |