Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues
Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with elevated bacterial endotoxin and residual debris, which poses a risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Acromium Flange Set (Custom product), Item No. PM555148, which is used for acromium replacement. The recall involves 219,988 units distributed nationwide in the United States and in 23 other countries, including Argentina, Australia, Brazil, Canada, and Japan.
The recall is being issued because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The agency has classified this recall as Class II.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 662230
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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