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Terminated

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

FDA Recall Z-1950-2016 · 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.

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