Z-0996-2009

Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001...

Name: Z-0996-2009 Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001...
Creator: Zimmer Inc.
Published: 2009-01-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-01-29 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of 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... on 2009-01-29. The reason FDA records is "The package contains 11 mm screws instead of the specified 6 mm screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0996-2009
Status: Terminated
Initiated: 2009-01-29
Posted: 2009-03-09
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The package contains 11 mm screws instead of the specified 6 mm screws.
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 3
Distribution: International Distribution only -- Country of Germany.
Product codes and lots: Lot 1635572.

Product code KRO

K013031Class IIMost Options SystemSulzer Orthopedics, Inc. / cleared 2001-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)