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U.S. Department of Health and Human Services

Class 2 Device Recall VerSys Hip System, Beaded Fullcoat Stems

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  Class 2 Device Recall VerSys Hip System, Beaded Fullcoat Stems see related information
Date Initiated by Firm May 19, 2014
Date Posted June 20, 2014
Recall Status1 Terminated 3 on March 24, 2015
Recall Number Z-1842-2014
Recall Event ID 68339
510(K)Number K973714  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Code Information 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.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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