Zimmer Inc. Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer, Winterthur, Switzerland; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Instructions for use/surgical technique instructions are inadequate.

Recommended Action

Per FDA guidance

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.