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

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

  • 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 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-0477-2014
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 Tibial Base Component 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
00450004100 62143211
00450004100 62215399
00450004100 62226572
00450004100 62239797
00450004100 62248808
00450004100 62285639
00450004100 62290853
00450004200 62143212
00450004200 62208157
00450004200 62208158
00450004200 62215401
00450004200 62220683
00450004200 62226573
00450004200 62248809
00450004200 62267650
00450004200 62285554
00450004200 62299545
00450004200 62393808
00450004200 62416048
00450004200 62419541
00450004300 62143213
00450004300 62160229
00450004300 62208159
00450004300 62215402
00450004300 62220681
00450004300 62220684
00450004300 62267645
00450004300 62279057
00450004300 62285555
00450004300 62285556
00450004300 62305745
00450004300 62305746
00450004300 62310757
00450004300 62349877
00450004300 62357515
00450004300 62368389
00450004300 62378070
00450004300 62397422
00450004300 62409042
00450004300 62416049
00450004300 62419542
00450004300 62442239
00450004300 62453785
00450004400 62168364
00450004400 62208160
00450004400 62215403
00450004400 62220686
00450004400 62232378
00450004400 62267647
00450004400 62297853
00450004400 62299546
00450004400 62299547
00450004400 62299548
00450004400 62343569
00450004400 62349879
00450004400 62372420
00450004400 62393809
00450004400 62397423
00450004400 62405323
00450004400 62409043
00450004500 62143215
00450004500 62215404
00450004500 62220688
00450004500 62232379
00450004500 62248810
00450004500 62254967
00450004500 62279058
00450004500 62299549
00450004500 62368390
00450004500 62378071
00450004600 62143216
00450004600 62239795
00450004600 62239796
00450004600 62248811
00450004600 62254968
00450004600 62285640
00450004600 62290855
00450004600 62405325
00830004100 62208152
00830004100 62316180
00830004100 62363978
00830004200 62204737
00830004200 62226574
00830004200 62239798
00830004200 62316181
00830004200 62337230
00830004200 62375878
00830004300 62204736
00830004300 62226575
00830004300 62232380
00830004300 62297854
00830004300 62323804
00830004300 62343570
00830004300 62372421
00830004300 62439685
00830004400 62204738
00830004400 62226576
00830004400 62232381
00830004400 62267658
00830004400 62323802
00830004400 62337231
00830004400 62375879
00830004500 62204739
00830004500 62232382
00830004500 62310759
00830004500 62331825
00830004500 62363980
00830004600 62239782
00830004600 62331826
00830004600 62357516
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 390 units (US) 129 units (outside of 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.
-
-