Recall Z-2420-2008 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Zimmer Inc.
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer, Winterthur, Switzerland; REF 01.00214.154. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)
| Date | Sep 26, 2008 (initiated Jul 22, 2008) |
| Status | Terminated |
| Reason | Instructions for use/surgical technique instructions are inadequate. |
| Root cause | Labeling False and Misleading |
| Action | 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 |
| Quantity | 19,014 of all products. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053536 | DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS Zimmer GmbH, Mar 16, 2006 |