Zimmer CBS 4.0 Countersink Recalled for Material Specification Deviation
Zimmer GmbH is recalling CBS 4.0 countersinks because they may have been manufactured from a material different from the defined specifications.
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 potential material deviation, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer GmbH is recalling the CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352. The recall was initiated after an investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products were distributed to 41 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, Texas, and Washington. All items marked with "Normed" are affected by this recall.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer GmbH for further instructions on return or replacement. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
- Manufacturer
- Zimmer GmbH
- Hazard
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)
- All items marked with "Normed" are affected
Distribution
Part of a larger recall action
This product is one of 76 recalled by Zimmer GmbH 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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