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 Recall Z-1616-2009 · Posted 2009-07-27
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2009-05-29
Date Terminated2009-12-22
Product Quantity147 of both products
Reason for Recall
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.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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