Zimmer GmbH Recalls AO Orthopedic Drills Due to Material Concerns
Zimmer GmbH is recalling specific AO orthopedic drills because they may be made from the wrong material. The products were distributed to 39 US states.
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 injuries, illnesses, or hospitalizations. The hazard is a potential material specification deviation, which fits the criteria for a moderate severity score.
Plain-English summary
Zimmer GmbH is recalling the Drill, 3.2x145mm, AO, Item Number 502015650. An investigation determined that these products were possibly manufactured from a different material than defined in the applicable specifications.
The affected items are identified by the marking "Normed." The products were distributed to 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.
Consumers and healthcare facilities should stop using these products and contact Zimmer GmbH for further instructions.
The recalled product
- Product
- Drill, 3.2x145mm, AO, Item Number 502015650
- 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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