Terminated

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 - 00588604417, 00588604510 TM CR TIB SZ 5 C-H, 12MM - 00588604512 TM CR TIB SZ 5 C-H, 14MM - 00588604514 TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 TM CR TIB SZ 6 C-H, 12MM 00588604612 TM CR TIB SZ 6 C-H, 14 MM 00588604614 TM CR TIB SZ 6 C-H, 17 MM 00588604617 TM CR TIB SZ 7 C-H, 10MM - 00588604710 TM CR TIB SZ 7 C-H, 12MM - 00588604712 TM CR TIB SZ 7 C-H, 14MM - 00588604714 TM CR TIB SZ 7 C-H, 17MM - 00588604717 TM CR TIB SZ 8 C-H, 10MM - 00588604810 TM CR TIB SZ 8 C-H, 12MM - 00588604812 TM CR TIB SZ 8 C-H, 14MM - 00588604814

FDA Recall Z-1951-2016 · Posted None

Recalling FirmZimmer Trabecular Metal Technology, Inc.

Recall StatusTerminated

Product CodeMBH

Date Initiated2016-04-15

Date Terminated2017-11-29

Product Quantity19,884 total

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.

Firm Action

Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide and Foreign.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031462THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTSImplex Corp. · 2003-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.