—#71763

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot 60985554.

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: International Distribution --- including Thailand.

Timeline

Recall initiated: 2008-06-09
Posted by FDA: 2008-09-11
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71763. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.