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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 Recall
Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
see related information
Date Posted December 10, 2013
Recall Status1 Open
Recall Number Z-0476-2014
Recall Event ID 66717
Premarket Notification
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 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 00450002300 62337759 00450002300 62349864 00450002300 62357505 00450002300 62357506 00450002300 62372417 00450002300 62375873 00450002300 62378065 00450002300 62409035 00450002300 62409036 00450002300 62416044 00450002300 62419537 00450002300 62453778 00450002400 62163383 00450002400 62208155 00450002400 62239778 00450002400 62267035 00450002400 62267036 00450002400 62267637 00450002400 62267638 00450002400 62297851 00450002400 62305741 00450002400 62305742 00450002400 62310754 00450002400 62316171 00450002400 62343554 00450002400 62343555 00450002400 62349866 00450002400 62368385 00450002400 62372419 00450002400 62375874 00450002400 62378066 00450002400 62393806 00450002400 62397421 00450002400 62405314 00450002400 62405315 00450002400 62409037 00450002400 62409038 00450002400 62416045 00450002400 62416047 00450002400 62419538 00450002400 62453782 00450002400 62459863 00450002400 62459864 00450002400 62459866 00450002500 11008421 00450002500 11008423 00450002500 62163384 00450002500 62208156 00450002600 62297850 00450002600 62310755 00450002600 62331806 00450002600 62331812 00450002600 62337209 00450002600 62349867 00450002600 62357508 00450002600 62358902 00450002600 62368387 00450002600 62405319 00450002600 62419540 00830002100 62264853 00830002100 62316175 00830002100 62323787 00830002100 62337211 00830002100 62349871 00830002100 62459838 00830002200 11009324 00830002200 62204732 00830002200 62215397 00830002200 62323788 00830002200 62331820 00830002200 62343566 00830002200 62430807 00830002300 62204765 00830002300 62220678 00830002300 62297852 00830002300 62323789 00830002300 62323794 00830002300 62331822 00830002300 62349872 00830002300 62357512 00830002300 62419528 00830002400 62208151 00830002400 62264855 00830002400 62316178 00830002400 62323790 00830002400 62343567 00830002400 62349873 00830002400 62405298 00830002500 62204734 00830002500 62215398 00830002500 62316176 00830002500 62323792 00830002500 62331823 00830002500 62337217 00830002500 62357513 00830002600 62239781 00830002600 62305744 00830002600 62316179 00830002600 62323796 00830002600 62337220 00830002600 62349874 00830002600 62393802 00830002600 62428995
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
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
PRODUCTION CONTROLS: 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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