Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
FDA Recall Z-2214-2010 · Posted 2010-08-12
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2010-04-06
Date Terminated2011-10-21
Product Quantity1972 all products
Reason for Recall
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Firm Action
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
Root Cause
Packaging
Distribution Pattern
US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
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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