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Recall Observatory FDA recall evidence

Device product

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

Z-0521-2020

August 21, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83783
Status
Terminated
Classification
Class II
Quantity
219988 units (total)
Official record key
device-enforcement:Z-0521-2020

Official wording

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

Code information: 662230

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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