Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential material deviation without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer GmbH is recalling Drill, cannulated, 2x95mm, round shaft, Item Number 502015619. 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 are identified by the code "Normed". These items were distributed to facilities in the following US states: 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.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer GmbH for further instructions regarding the return or replacement of the products.
The recalled product
- Product
- Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
- 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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