Z-1952-2016Class II

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...

Name: Z-1952-2016 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...
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 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... 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-1952-2016
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 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
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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1952-2016
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)