—#94181

Product

Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K021891
Affected lot / code info: 61091653

Why it was recalled

The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.

Root cause (FDA determination)

Other

Action the firm took

The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.

Timeline

Recall initiated: 2010-08-18
Posted by FDA: 2010-10-14
Terminated: 2011-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.