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Zimmer Biomet, Inc. recalls ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Recalled December 4, 2019 · FDA recall Z-0521-2020 · Zimmer Biomet
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. · FDA Class II
Units
219988 units (total)
Sold at
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.
Description
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →