Z-0522-2020 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
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
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
664030