—#90687

Product

Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, 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 product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061067
Affected lot / code info: 60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530.

Why it was recalled

The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.

Timeline

Recall initiated: 2010-04-06
Posted by FDA: 2010-08-12
Terminated: 2011-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90687. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.