Zimmer V-TEK IVP Step Drill Recalled for Material Specification Deviation
Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a different material than specified.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential material deviation without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer GmbH is recalling V-TEK IVP step drills (2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634) 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 were distributed to 38 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, and Texas. All items marked with "Normed" are affected by this recall.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer GmbH for further instructions or replacement.
The recalled product
- Product
- V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
- 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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