Z-2300-2008

Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used...

Name: Z-2300-2008 Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used...
Creator: Zimmer Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-06-30 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw... on 2008-06-30. The reason FDA records is "An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2300-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-17
Terminated: 2008-12-17
Recalling firm: Zimmer GmbH
Product: Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
Quantity in commerce: 5
Distribution: Florida, China and India.
Product codes and lots: Lot 60954069.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)