Stryker 15mm Drill Recalled for Potential Material Deviation
Zimmer GmbH is recalling Stryker 15mm drills because an investigation found they 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. The hazard involves a potential material deviation in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer GmbH is recalling Stryker 15mm stop drills (Item Number 502015114) due to a potential material deviation. An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products are distributed across 37 US states, including Alabama, Arizona, California, Florida, New York, and Texas. All items marked with "Normed" are affected by this recall.
Healthcare facilities and users should stop using the affected drills and contact Zimmer GmbH for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
- 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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