Z-1953-2016Class II

Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn Sz 5 12Mm - 00588606512 Tm Mono Tib Str Grn Sz 5...

Name: Z-1953-2016 Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn Sz 5 12Mm - 00588606512 Tm Mono Tib Str Grn Sz 5...
Creator: Zimmer Trabecular Metal Technology, Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

Zimmer Trabecular Metal Technology, Inc. / initiated 2016-04-15 / Terminated / root cause: packaging

FDA source

Zimmer Trabecular Metal Technology, Inc. began a recall of 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 -... on 2016-04-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1953-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-06-10
Terminated: 2017-11-29
Recalling firm: Zimmer Trabecular Metal Technology, Inc.
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
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1953-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1951-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1952-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1953-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1954-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1955-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10

Product code MBH

K031462Class IIThe Nexgen Knee System Uncemented ComponentsImplex Corp. / cleared 2003-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)