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 material different from the applicable specifications.
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 does not report any illnesses, injuries, or deaths. The hazard is a potential material deviation, which fits the criteria for a moderate severity score.
Plain-English summary
Zimmer GmbH is recalling V-TEK IVP step drills, specifically the 2-3.4x124mm, 16mm stop, AO model (Item Number 502015636). 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 numerous US states, including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. All items marked with "Normed" are affected.
Healthcare providers and consumers should stop using the affected step drills and contact Zimmer GmbH for further instructions or a replacement.
The recalled product
- Product
- V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636
- 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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