Z-2179-2008

Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at...

Name: Z-2179-2008 Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at...
Creator: Zimmer Inc.
Published: 2008-06-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-06-09 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for... on 2008-06-09. The reason FDA records is "An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body". 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-2179-2008
Status: Terminated
Initiated: 2008-06-09
Posted: 2008-09-11
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.
Product code: HRS Plate, Fixation, Bone
Reason for recall: An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance.
Quantity in commerce: 7
Distribution: International Distribution --- including Thailand.
Product codes and lots: Lot 60985554.

Product code HRS

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

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)