Z-0522-2020 Class II Terminated
FDA device recall Z-0522-2020 was initiated by Zimmer Biomet, Inc. on August 21, 2019 and is designated Class II. Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. The recall status is terminated (terminated July 21, 2021). Affected quantity: 219988 units (total).
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