FDA-Device2016-06-22Class II

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

Zimmer Trabecular Metal Technology, Inc.
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.

Sold states
Nationwide and Foreign.
Affected count
19,884 total
Manufactured in
10 Pomeroy Rd, Parsippany, NJ, United States
Products
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2016

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