VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
FDA device recall Z-1842-2014 · posted 2014-06-20 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 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, Domi
- Date initiated
- 2014-05-19
- Date posted
- 2014-06-20
- Date terminated
- 2015-03-24
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSYS HIP SYSTEM BEADED HIP PROSTHESIS (K973714) | Zimmer, Inc. | 1997-12-24 |