Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns
Zimmer GmbH is recalling specific cannulated drills 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 defect that could affect performance or safety, but no specific injuries or illnesses are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Zimmer GmbH is recalling the Drill, cannulated, 4x120mm, AO, Item Number 502015402. 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 hospitals and medical facilities in 39 US states, including Alabama, Arizona, California, Florida, New York, and Texas. The recall number is Z-1435-2019.
Healthcare facilities should stop using the affected drills and contact Zimmer GmbH for instructions on how to return or dispose of the products. Patients who have had these drills used during a procedure should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Drill, cannulated, 4x120mm, AO, Item Number 502015402
- 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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