Zimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues
Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to 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 medical device with a risk of harm (bacterial endotoxin and debris) where no specific injuries or illnesses have been 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 specific BIOMOD PORCOAT HA GLENTRAY Custom Shoulder Products used for total shoulder replacement. The recall involves Item Nos. PM0000097, PM555140, PM555147, PM555319, PM555418, 113867, 113865, and 113863.
The recall is being conducted because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The affected units were distributed nationwide in the US 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 instructions on how to proceed with the recall. The source text does not specify the number of affected units, specific lot numbers, or reported illnesses.
The recalled product
- Product
- BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 214,741
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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