—#71981

Product

Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-01 and 00-6428-028-01. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030724
Affected lot / code info: All lots.

Why it was recalled

When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.

Root cause (FDA determination)

Device Design

Action the firm took

The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.

Timeline

Recall initiated: 2008-06-11
Posted by FDA: 2008-11-21
Terminated: 2009-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.