Recall Z-0996-2009 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Inc.
Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
| Date | Mar 9, 2009 (initiated Jan 29, 2009) |
| Status | Terminated |
| Reason | The package contains 11 mm screws instead of the specified 6 mm screws. |
| Root cause | Packaging process control |
| Action | The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA t |
| Quantity | 3 |
| Distribution | International Distribution only -- Country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013031 | MOST OPTIONS SYSTEM Sulzer Orthopedics, Inc., Dec 7, 2001 |