Zimmer GmbH Recalls Osteofresh Arthrodesis Drills Due to Material Concerns
Zimmer GmbH is recalling specific Osteofresh arthrodesis drills because they may have been manufactured from a material different from the 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 compromise safety, but the source text explicitly states no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer GmbH is recalling specific Osteofresh arthrodesis drills, identified by Item Number 502015213. The recall involves drills that are 2x70mm with a center tip, AO, and 10mm stop. The products were distributed to numerous US states, including Alabama, Arizona, California, Florida, New York, and Texas.
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. The source text does not report any illnesses, injuries, or deaths associated with these devices.
Consumers and healthcare providers should check their inventory for these specific items. All items marked with "Normed" are affected. Users should stop using the affected drills and contact Zimmer GmbH for further instructions.
The recalled product
- Product
- Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
- 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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