Medical device recalls Moderate risk

Zimmer Trabecular Metal Technology, Inc. recalls POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 005878065…

Recall date
April 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1950-2016
FDA classification
Class II
Brand / firm
Zimmer Trabecular Metal Technology, Inc.
Sold / distributed
Nationwide and Foreign.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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