—#127373

Product

VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K973714
Affected lot / code info: Item # 784301108, Lot #'s: 62478967, 62479742, 62503408, 62528282, 62530786, 62544915, 62554360; Item # 784301126, Lot #: 62544885, 62547211, Item # 784301156, Lot #, 62587079; Item # 784301208, Lot #'s: 62503411, 62509385, 62530790, 62547217, 62554362; Item # 784301226, Lot #'s: 62515502, 62547216; Item # 784301256, Lot #'s: 62489572, 62522386; Item # 784301326, Lot #, 62496464, 62594428, 62622893; Item # 784301356, Lot #: 62622894; Item # 784301382, Lot #: 62544907; Item # 784301511, Lot #: 62472423 & Item # 784301581, Lot #: 62496469.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-19
Posted by FDA: 2014-06-20
Terminated: 2015-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.