Zimmer Biomet Recalls Hennessy Left Constrained Glenoid Shoulder Implants
Zimmer Biomet is recalling Hennessy Left Constrained Glenoid Humeral Shoulder Implants due to elevated bacterial endotoxin and residual debris caused by a cleaning issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a contamination hazard (bacterial endotoxin and debris) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 219,988 units of Hennessy Left Constrained Glenoid Humeral Shoulder Implants (Item No. PM555360). The recall is due to elevated levels of bacterial endotoxin and residual debris remaining on the devices, which is attributed to a cleaning issue.
The affected devices were distributed nationwide in the United States and in several international countries, including 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.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or removal of the devices.
The recalled product
- Product
- HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 664030
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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