Zimmer Biomet, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0522-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2019.
Data Source: FDA.
Product Description:
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Product Classification:
Class II
Date Initiated: August 21, 2019
Date Posted: December 4, 2019
Recall Number: Z-0522-2020
Event ID: 83783
Reason for Recall:
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Status: Terminated
Product Quantity: 219988 units (total)
Code Information:
664030
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.
Voluntary or Mandated:
Voluntary: Firm initiated