Zimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues
Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products 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 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 various custom medical devices, identified by numerous item numbers and lot codes, due to a manufacturing cleaning issue. The recall affects 219,988 units that 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. This contamination resulted from a cleaning issue during the manufacturing process. The affected lots were manufactured between January 2008 and May 2019.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to handle the affected devices. The company is working to resolve the issue and ensure patient safety.
The recalled product
- Product
- Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114
- 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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