Acromium Flange SET recall: Endotoxin
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Why was Acromium Flange SET recalled?
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
662230
- Product
- ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 219988 units (total)
- Distribution
- 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.
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)