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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-0476-2014
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 Right 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
00450002100 62163375
00450002100 62248804
00450002100 62248805
00450002100 62267632
00450002100 62279047
00450002500 62220671
00450002500 62220675
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00450002500 62442236
00450002600 11007905
00450002600 62163386
00450002600 62262903
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00450002100 62287975
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00830002200 11009324
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00830002500 62323792
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00830002500 62357513
00830002600 62239781
00830002600 62305744
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00830002600 62323796
00830002600 62337220
00830002600 62349874
00830002600 62393802
00830002600 62428995
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
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 265 units (US) 114 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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