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U.S. Department of Health and Human Services

Class 2 Device Recall VerSys Heritage

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 Class 2 Device Recall VerSys Heritage see related information
Date Posted February 20, 2014
Recall Status1 Open
Recall Number Z-1028-2014
Recall Event ID 66500
PMA Number P040048 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented - Product Code MRA
Product VERSYS HERITAGE FEM STEM
Code Information 60888636
60953044
60953045
60990022
60990023
61037925
61101347
61190038
61199991
61216692
61231958
61337105
61337106
61337108
61337109
61380551
61393846
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61395481
61395482
61457789
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61501472
61528642
61607607
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61631108
61636270
61640544
61658343
61727080
61795011
61803866
61830030
61841636
61841637
61859438
61860472
61878469
61880368
61903233
61936199
61980174
62001339
62024623
62055989
62055991
62097061
62106808
62143853
62147329
62147330
62199398
62199399
62213245
62232590
62240777
62257146
62268582
62268583
62281833
62298293
62305944
369871
61282966
61727082
61962092
369672
61189806
61266267
61294351
369898
61293625
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
800-613-6131
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged pro
FDA Determined
Cause 2
Packaging change control
Action Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
Quantity in Commerce 7,044,680 total
Distribution Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MRA and Original Applicant = ZIMMER, INC.
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