—#78236

Product

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.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013031
Affected lot / code info: Lot 1635572.

Why it was recalled

The package contains 11 mm screws instead of the specified 6 mm screws.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: International Distribution only -- Country of Germany.

Timeline

Recall initiated: 2009-01-29
Posted by FDA: 2009-03-09
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.