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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components

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 Class 2 Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components see related information
Date Posted December 10, 2013
Recall Status1 Terminated on October 15, 2014
Recall Number Z-0475-2014
Recall Event ID 66717
510(K)Number K120906 
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.
Code Information Part Number Lot Number
00450001100 62072174
00450001100 62248802
00450001100 62264833
00450001100 62267033
00450001100 62279041
00450001100 62279043
00450001100 62331803
00450001100 62331808
00450001100 62337755
00450001100 62343558
00450001100 62357496
00450001100 62357497
00450001100 62397412
00450001100 62397413
00450001100 62430803
00450001200 11007903
00450001200 11008443
00450001200 62168362
00450001200 62239775
00450001200 62239789
00450001200 62267626
00450001200 62267627
00450001200 62279044
00450001200 62279050
00450001600 62168363
00450001600 62239794
00450001600 62264836
00450001600 62264837
00450001600 62267631
00450001600 62290823
00450001600 62290824
00450001600 62297847
00450001600 62297848
00450001600 62310752
00450001600 62316170
00450001600 62323809
00450001600 62331810
00450001600 62337757
00450001600 62349862
00450001600 62357499
00450001600 62372416
00450001600 62405309
00450001600 62419534
00450001200 62285546
00450001200 62290833
00450001200 62290835
00450001200 62372414
00450001200 62375863
00450001200 62397414
00450001200 62405304
00450001200 62416035
00450001200 62419530
00450001200 62430804
00450001300 62160227
00450001300 62163379
00450001300 62215393
00450001300 62264834
00450001300 62267628
00450001300 62267629
00450001300 62279045
00450001300 62279051
00450001300 62285548
00450001300 62290836
00450001300 62299551
00450001300 62331811
00450001300 62337756
00450001300 62349856
00450001300 62349857
00450001300 62368383
00450001300 62375865
00450001300 62375868
00450001300 62378060
00450001300 62397415
00450001300 62397416
00450001300 62409032
00450001300 62409033
00450001300 62416036
00450001300 62419532
00450001300 62430805
00450001400 11007904
00450001400 11008529
00450001400 62163382
00450001400 62208153
00450001400 62239776
00450001400 62239786
00450001400 62264835
00450001400 62279052
00450001400 62290829
00450001400 62299552
00450001400 62305739
00450001400 62310750
00450001400 62316168
00450001400 62316169
00450001400 62343549
00450001400 62343550
00450001400 62343551
00450001400 62349858
00450001400 62368384
00450001400 62372415
00450001400 62378062
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00450001400 62393804
00450001400 62397417
00450001400 62405306
00450001400 62409034
00450001400 62416038
00450001400 62416039
00450001400 62416040
00450001400 62419533
00450001400 62459855
00450001500 62072172
00450001500 62208154
00450001500 62215392
00450001500 62220672
00450001500 62220674
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00450001500 62279046
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00450001500 62358906
00450001500 62378063
00450001500 62393805
00450001500 62397418
00450001500 62405308
00450001500 62416042
00450001500 62439673
00450001600 11007906
Part Number Lot Number
00830001100 62264850
00830001100 62316172
00830001100 62323776
00830001100 62337212
00830001100 62357509
00830001200 62204729
00830001200 62215395
00830001200 62316173
00830001200 62323778
00830001200 62331816
00830001200 62343559
00830001300 11008422
00830001300 62204730
00830001300 62220676
00830001300 62267038
00830001300 62267040
00830001300 62323781
00830001300 62331817
00830001300 62337216
00830001300 62349869
00830001300 62409040
00830001400 62208150
00830001400 62264851
00830001400 62310756
00830001400 62316177
00830001400 62323783
00830001400 62343560
00830001400 62343561
00830001400 62368388
00830001500 62204731
00830001500 62215396
00830001500 62305743
00830001500 62323784
00830001500 62343563
00830001500 62357510
00830001500 62428994
00830001600 62264852
00830001600 62299553
00830001600 62316174
00830001600 62323786
00830001600 62337210
00830001600 62343565
00830001600 62357511
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall
As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media
FDA Determined
Cause 2
Manufacturing material removal
Action Zimmer sent an URGENT MEDICAL DEVICE RECALL notification letter dated November 12, 2013 to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to locate and remove the affected product from their inventory and notify their Zimmer representataive. The Zimmer representative will remove the recalled product from their facility. For patients that previously had the affected product implanted, consignees were instructed to continue their operative follow up routine. Consignees with questions were instructed to call 1-877-946-2761. For questions regarding this recall call 800-613-6131.
Quantity in Commerce 269 units (US) 110 units (outside US)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
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.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = ZIMMER, INC.
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