Recall Z-1953-2016— Zimmer Trabecular Metal Technology, Inc.

Name: FDA recall Z-1953-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by Zimmer Trabecular Metal Technology, Inc., initiated 2016-04-15, terminated 2017-11-29. It names one FDA 510(k) clearance: K031462. 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. Reason: 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..

Recalling firm: Zimmer Trabecular Metal Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2017-11-29
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031462 — THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTSImplex Corp.·cleared 2003-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.