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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot 1635572.
Products Sold
Lot 1635572.
Zimmer Inc. is recalling Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-00 due to The package contains 11 mm screws instead of the specified 6 mm screws.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The package contains 11 mm screws instead of the specified 6 mm screws.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026