Zimmer GmbH Recalls Contra-Angle Drills Due to Material Concerns
Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified.
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 is classified as FDA Class II, and the hazard involves a potential material deviation in a medical device, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling specific contra-angle drills (Item Number ST502015706) because an investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products are marked with "Normed" and were distributed to numerous US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, Texas, and Washington. The recall is classified as Class II by the FDA.
Healthcare providers and consumers should stop using the affected drills and contact Zimmer GmbH for further instructions or a replacement.
The recalled product
- Product
- Drill, contra-angle, 1.5x85mm, Item Number ST502015706
- 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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