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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm April 15, 2016
Create Date June 10, 2016
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-1953-2016
Recall Event ID 73536
510(K)Number K031462  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product TM MONO TIB STR GRN SZ 5 - 00588606510
TM MONO TIB STR GRN SZ 5 12MM - 00588606512
TM MONO TIB STR GRN SZ 5 14MM - 00588606514
TM MONO TIB STR GRN SZ 5 17MM - 00588606517
TM MONO TIB STR GRN SZ 6 10MM - 00588606610

TM MONO TIB STR GRN SZ 6 12MM - 00588606612

TM MONO TIB STR GRN SZ 6 14MM - 00588606614
TM MONO TIB STR GRN SZ 6 17MM - 00588606617
TM MONO TIB STR BLUE SZ 7 10MM - 00588606710
TM MONO TIB STR BLUE SZ 7 12MM - 00588606712
TM MONO TIB STR BLUE SZ 7 14MM - 00588606714
TM MONO TIB STR BLUE SZ 7 17MM - 00588606717
TM MONO TIB STR GRN SZ 5 10MM - 00588607510
TM MONO TIB STR GRN SZ 5 12MM - 00588607512
TM MONO TIB STR GRN SZ 5 14MM - 00588607514
TM MONO TIB STR GRN SZ 5 17MM - 00588607517
Code Information 00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934 00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358 00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935 00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936 61809005 00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718 61839382 00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375 61809018 61844376 00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015 00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719 00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763 00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235 00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058 00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249 00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346 00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753 00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931 00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370
Recalling Firm/
Manufacturer		 Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact Product Service Department
973-576-0032
Manufacturer Reason
for Recall		 Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.
Quantity in Commerce 19,884 total
Distribution Nationwide and Foreign.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = IMPLEX CORP.
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