HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Reported: December 4, 2019 Initiated: August 21, 2019 #Z-0522-2020
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.. Recalled by Zimmer Biomet, Inc.. Units affected: 219988 units (total).
Why was this product recalled? ▼
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0522-2020.
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