• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MagnaFx Cannulated Screw Fixation System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MagnaFx Cannulated Screw Fixation System see related information
Date Posted February 20, 2014
Recall Status1 Open
Recall Number Z-1001-2014
Recall Event ID 66500
Product Classification Screw, fixation, bone - Product Code HWC
Product Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Code Information 60363974
60368347
60380998
60391978
60406078
60422626
60432909
60435944
60452027
60452028
60472793
60479167
60514787
60535990
60550178
60569288
60569290
60583327
60628488
60671920
60671921
60671922
60686383
60714690
60714691
60751749
60763772
60798065
60820092
60820093
60845526
60868356
60918775
60974971
60988151
60991274
61010717
61013662
61033117
61035551
61041404
61053668
61108010
61136253
61172714
61200607
61245871
61282210
61420565
61440254
61523998
61538074
61627292
61678539
61812130
60096605
60109527
60123363
60132556
60145182
60155282
60172560
60186824
60207625
60242166
60293164
60352037
60363977
60391980
60422627
60444834
60509133
60535991
60569291
60671923
60686386
60714692
60789526
60798066
60829373
60959826
60983897
61033119
61053669
61074867
61108012
61136254
61226803
61383149
61458930
61538081
61693569
60390321
60101472
60105509
60117004
60132557
60144779
60150065
60165577
60169761
60178265
60190835
60195094
60218163
60264356
60279163
60279168
60309819
60323269
60381002
60391982
60422628
60435945
60448356
60472794
60479168
60509134
60535993
60550179
60576796
60671924
60686388
60714693
60735828
60751780
60789527
60820094
60832608
60954623
60959823
61010742
61033127
61041405
61053671
61108014
61136255
61141532
61268912
61286977
61414308
61466749
61700322
62265702
60097906
60109529
60123364
60135203
60165578
60195095
60218904
60323270
60356447
60391984
60406079
60444835
60514789
60569292
60686395
60734468
60763774
60806137
60820095
60885524
60954621
60959821
61035552
61058210
61108015
61141533
61226804
61286979
61664711
62144744
62265704
60342079
60391986
60123365
60135204
60154188
60178877
60186825
60195096
60218905
60264357
60323271
60337962
60381003
60406080
60435946
60444832
60509135
60550180
60569293
60686398
60714695
60749368
60806138
60820096
60932406
61037321
61108017
61108019
61141534
61282211
61309366
61620157
61700323
62122190
60097907
60123366
60165579
60201187
60309820
60358065
60444836
60448057
60751813
60763775
60878286
60914264
61053672
61108021
61129832
61291483
62112509
60793322
60123367
60144780
60157575
60167138
60207627
60231226
60279169
60352038
60381004
60444833
60528744
60714697
60776682
60820097
60878333
61041406
61108022
61282212
61627294
61707847
62140576
60117005
60201188
60341868
60363978
60671928
60751824
60829374
60959825
60983907
61053675
61108023
61197679
61627295
61678554
61681722
61707848
60368348
60207628
60381006
60714699
60806139
60878344
61053674
61129833
61286981
60137571
60368349
60806140
60885525
60914266
61129834
61286982
60137572
60356448
60734469
60754882
60885526
61037322
61058213
61144150
60341869
60391988
61041407
61074869
61136256
61820855
62134725
60207632
60391990
60914268
61108025
61136257
62101333
60391992
60391993
60885529
60959824
61108031
61249291
60356114
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 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.
-
-