Home / Recalls / Zimmer Trabecular Metal Technology, Inc. / Z-1953-2016

Z-1953-2016 Class II Terminated

Recalled by Zimmer Trabecular Metal Technology, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
June 22, 2016
Initiation Date
April 15, 2016
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,884 total

Product Description

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

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.

Distribution Pattern

Nationwide and Foreign.

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

Other recalls by Zimmer Trabecular Metal Technology, Inc.

  • Z-1005-2019 Class II — NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Si (February 1, 2019)
  • Z-1006-2019 Class II — NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Si (February 1, 2019)
  • Z-1892-2017 Class III — The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device (July 7, 2016)
  • Z-1955-2016 Class II — 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MM (April 15, 2016)
  • Z-1950-2016 Class II — POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058780 (April 15, 2016)
  • Z-1952-2016 Class II — TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886053 (April 15, 2016)
  • Z-1954-2016 Class II — REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 (April 15, 2016)
  • Z-1951-2016 Class II — TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886043 (April 15, 2016)
  • Z-1325-2015 Class II — NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D (February 4, 2015)
  • Z-0851-2015 Class II — NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial (December 2, 2014)