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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-0475-2014
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 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 00450001400 62393803 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 00450001500 62226570 00450001500 62279046 00450001500 62279053 00450001500 62285550 00450001500 62290842 00450001500 62331809 00450001500 62349859 00450001500 62349861 00450001500 62357498 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, 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 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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