Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues
Zimmer Biomet is recalling Copeland HA Resurfacing Heads 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 FDA classified this as a Class II recall involving 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 the Copeland HA Resurfacing Head and MB/HA EAS Head, used for partial shoulder replacement. The recall covers 219,988 units manufactured between January 2008 and May 2019. These devices were distributed nationwide in the United States and in 24 other countries, including Argentina, Australia, Brazil, Canada, and Japan.
The recall was initiated because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received these devices should contact their healthcare provider for guidance on next steps. Consumers should not attempt to remove the device themselves and should consult with a qualified medical professional regarding the potential risks associated with the cleaning issue.
The recalled product
- Product
- Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Pr
- 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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