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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-1952-2016
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 LPS TIB SZ 3 C/D, 10MM - 00588605310

TM LPS TIB SZ 3 C/D, 12MM - 00588605312

TM LPS TIB SZ 3 C/D, 14MM - 00588605314

TM LPS TIB SZ 3 C/D, 17MM - 00588605317

TM LPS TIB SZ 4 C/D, 10MM - 00588605410

TM LPS TIB SZ 4 C/D, 12MM - 00588605412

TM LPS TIB SZ 4 C/D, 14MM - 00588605414

TM LPS TIB SZ 5 E/F 10 MM - 00588605510

TM LPS TIB SZ 5 E/F, 12MM - 00588605512

TM LPS TIB SZ 5 E/F, 14MM - 00588605514

TM LPS TIB SZ 5 E/F, 17MM - 00588605517

TM LPS TIB SZ 6 E/F, 10MM - 00588605610

TM LPS TIB SZ 6 E/F, 12 mm - 00588605612

TM LPS TIB SZ 6 E/F, 17MM - 00588605617

TM LPS TIB SZ 7 G/H, 10MM - 00588605710

TM LPS TIB SZ 7 G/H, 12MM - 00588605712

TM LPS TIB SZ 7 G/H, 14MM - 00588605714

TM LPS TIB SZ 8 G/H, 10MM - 00588605810

TM LPS TIB SZ 8 G/H, 12MM - 00588605812

TM LPS TIB SZ 8 G/H, 14MM - 00588605814

TM LPS TIB SZ 8 G/H, 14MM - 00588605814

TM LPS TIB SZ 8 G/H, 17MM - 00588605817

TM LPS TIB SZ 3 E/F, 10MM - 00588606310

TM LPS TIB SZ 3 E/F, 12MM - 00588606312

TM LPS TIB SZ 3 E/F, 14MM - 00588606314

TM LPS TIB SZ 3 E/F, 17MM - 00588606317

TM LPS TIB SZ 4 E/F, 10MM - 00588606410

TM LPS TIB SZ 4 E/F, 12MM -00588606412

TM LPS TIB SZ 4 E/F, 14MM - 00588606414
Code Information 00588605310 TM LPS TIB SZ 3 C/D, 10MM 61776840 61770817 61785352 61792636 61814243 61833815 61844337 61844340 61844341 00588605312 TM LPS TIB SZ 3 C/D, 12MM 61746696 61770813 61785354 61797196 61851748 00588605314 TM LPS TIB SZ 3 C/D, 14MM 61759785 61770812 61797197 00588605317 TM LPS TIB SZ 3 C/D, 17MM 61746694 61759789 61785353 00588605410 TM LPS TIB SZ 4 C/D, 10MM 61733406 61803955 61808992 61833823 61839387 61839369 00588605412 TM LPS TIB SZ 4 C/D, 12MM 61733410 61844343 00588605414 TM LPS TIB SZ 4 C/D, 14MM 61759795 61803956 00588605510 TM LPS TIB SZ 5 E/F, 10MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755  00588605612 TM LPS TIB SZ 6 E/F, 12MM 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646  00588605510 TM LPS TIB SZ 5 E/F 10 MM   61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226  00588605512 TM LPS TIB SZ 5 E/F, 12MM  61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227  00588605514 TM LPS TIB SZ 5 E/F, 14MM  61746717 61770829 61785372 61792662  00588605517 TM LPS TIB SZ 5 E/F, 17MM  61746718 61770828 61809007  00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755  00588605612 TM LPS TIB SZ 6 E/F, 12 mm 61759777 61769563 61770836 61785383 61792668 61809022 61844375  00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357  00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646
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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