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Terminated

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.

FDA Recall Z-2179-2008 · Posted 2008-09-11

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2008-06-09
Date Terminated2009-11-12
Product Quantity7

Reason for Recall

An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

International Distribution --- including Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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