Z-0521-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- August 21, 2019
- Termination Date
- July 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 219988 units (total)
Product Description
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Reason for Recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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.
Code Information
662230