—#90686

Product

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 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: 60492194, 60531068, 60530835, 60724676, 60680532, 60770940, 60796676, 60904592, 61195210, 61076505, 61424513 and 61424514.

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 #90686. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.