Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. Component used to
FDA device recall Z-0996-2009 · posted 2009-03-09 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The package contains 11 mm screws instead of the specified 6 mm screws.
- Action taken
- 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 to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 3
- Distribution
- International Distribution only -- Country of Germany.
- Date initiated
- 2009-01-29
- Date posted
- 2009-03-09
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOST OPTIONS SYSTEM (K013031) | Sulzer Orthopedics, Inc. | 2001-12-07 |