—#90688

Product

Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, 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: 60492196, 60531086, 60703467, 60667441, 60728123, 60767106, 60787931, 60808260, 60904605, 61024439, 61143012, 61217116 and 61355988.

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 #90688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.