Zimmer Trabecular Metal Technology, Inc.: 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 - 0058860531

Is my product affected?

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

• UPC 00588605310
• UPC 00588605312
• UPC 00588605314
• UPC 00588605317
• UPC 00588605410
• UPC 00588605412
• UPC 00588605414
• UPC 00588605510
• UPC 00588605512
• UPC 00588605514
• UPC 00588605517
• UPC 00588605610
• UPC 00588605612
• UPC 00588605617
• UPC 00588605710
• UPC 00588605712
• UPC 00588605714
• UPC 00588605810
• UPC 00588605812
• UPC 00588605814
• UPC 00588605817
• UPC 00588606310
• UPC 00588606312
• UPC 00588606314
• UPC 00588606317
• UPC 00588606410
• UPC 00588606412
• UPC 00588606414

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012. The implants come in foil pouches that are part of a dual barrier system designed to maintain sterile integrity. A total of 19,884 units have been distributed nationwide and internationally across multiple product sizes and lot numbers.

The recall affects Trabecular Metal LPS TIB implants in various sizes (10MM, 12MM, 14MM, and 17MM) across different product categories. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: Nationwide and Foreign. Quantity: 19,884 total Lot/code info: 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 0058860571

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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• TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM - 00588604414 TM CR TIB SZ 4 C-H, 17MM - 2016-04-15
• 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 - 0058860662016-04-15
• REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 02016-04-15

All FDA (Device enforcement) recalls