Recall Z-0416-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necros
| Date | Nov 21, 2012 (initiated Sep 20, 2012) |
| Status | Terminated |
| Reason | Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported. |
| Root cause | Process control |
| Action | Zimmer sent a Urgent Medical Device Recall Notice dated September 20, 2012, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customer. Customers were instructed to locate quarantine and return affected product to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 for product in the USA. Customers were asked to complete the Inventory Return Certification Form and follow the instructions where to return this form. For further questions please call (574) 372-4807. |
| Quantity | 24 USA; 71 worldwide |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.