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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 Initiated by Firm October 11, 2013
Date Posted February 20, 2014
Recall Status1 Open3, Classified
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, 61395480, 61395481, 61395482, 61457789, 61488608, 61501472, 61528642, 61607607, 61613260, 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
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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MRA and Original Applicant = ZIMMER, INC.
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