—#82390

Product

Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02. Orthopedic implant used in total hip arthroplasty.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030724
PMA numbers: P040048
Affected lot / code info: Lot Number: 61007046.

Why it was recalled

The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.

Timeline

Recall initiated: 2009-05-29
Posted by FDA: 2009-07-27
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.