Recall Z-1950-2016— Zimmer Trabecular Metal Technology, Inc.

Name: FDA recall Z-1950-2016
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: POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541. 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

POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541

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.