Recall Z-0060-2011 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
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.
| Date | Oct 14, 2010 (initiated Aug 18, 2010) |
| Status | Terminated |
| Reason | The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter. |
| Root cause | Other |
| Action | 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 |
| Quantity | 24 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021891 | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc., Sep 5, 2002 |