Zimmer Biomet, Inc. recalls ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.

Recall date: August 21, 2019
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-0521-2020
FDA classification: Class II
Brand / firm: Zimmer Biomet, Inc.
Sold / distributed: US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

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

ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.

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