Zimmer Biomet Recalls Shoulder Baseplates Due to Cleaning Issues
Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
What this means for you
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 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 COMP RVRS Shoulder Baseplates, including custom products, due to a cleaning issue. The recall affects 219,988 units manufactured between January 2008 and May 2019.
The devices are being recalled because elevated levels of bacterial endotoxin and residual debris remain on them. The affected products were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, and others.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
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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