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U.S. Department of Health and Human Services

Class 2 Device Recall VersaFx Femoral Fixation System

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 Class 2 Device Recall VersaFx Femoral Fixation System see related information
Date Posted February 20, 2014
Recall Status1 Open
Recall Number Z-1006-2014
Recall Event ID 66500
510(K)Number K830196¿(versa 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9

Item codes starting with 001980, 001981, 0011990 and 0011991
Code Information 60053473
60528659
60807849
60855076
365855
60807850
60855077
365856
60143351
60384033
60403721
60452546
60543211
60632720
60807851
368913
369123
60219007
60740783
60993433
365857
369559
371074
60539739
60807852
365859
60098398
60119108
60241936
60625494
60082810
60625506
365860
365861
60222477
60109715
60187232
366023
60161891
60116180
60175536
365749
60082811
60109716
60123966
60175537
60231394
60097992
60119110
60123967
60143352
60154511
60165702
60175538
60231395
365740
366424
60109717
60112053
60112054
60116181
60116182
60119111
60119112
60129316
60129317
60154512
60154513
60165703
60175539
60187233
60187234
60206858
60206859
60241934
60161892
365739
60109718
365738
60123968
366024
366025
60136407
365752
365751
60123969
60154514
60082812
60109719
365753
365743
60163222
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.
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