—#72743

Product

Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer, Winterthur, Switzerland; REF 01.00214.150. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K053536
Affected lot / code info: All units.

Why it was recalled

Instructions for use/surgical technique instructions are inadequate.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

A press release issued on 7/23/08. A letter was sent to implanting surgeons on 7/22/08 advising them of the problem and instructing them to stop implanting these devices until they receive training. Zimmer suspended all marketing and distribution in the U.S. pending completion of user training and revision of the instructions for surgical technique. Zimmer will conduct a removal of all copies of the current surgical technique document and replace it with revised surgical technique document(s). Contact Zimmer, Inc. at 1-866-946-5633 for assistance. Update: A dear surgeon letter was mailed 8/4/08 and provided patient management guidelines. A correction update was sent 8/16/08 with updated surgical technique and instructions for use documents. A dear surgeon letter was mailed 9/25/08 providing additional information regarding the training program.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2008-07-22
Posted by FDA: 2008-09-26
Terminated: 2009-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72743. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.