Recall Z-1842-2014 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer, Inc.
VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
| Date | Jun 20, 2014 (initiated May 19, 2014) |
| Status | Terminated |
| Reason | During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively. |
| Root cause | Nonconforming Material/Component |
| Action | On 6/2/2014 the firm sent "Urgent Medical Device Recall" letters to their customers. On 8/13/14, Zimmer contacted a distributor via phone pertaining to one additional lot (00-7843-011-06; lot 62547211) which had been included in the recall. Formal recall notices were issued to the distributor via email on 8/15/14. |
| Quantity | 147 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973714 | VERSYS HIP SYSTEM BEADED HIP PROSTHESIS Zimmer, Inc., Dec 24, 1997 |