Zimmer GmbH Recalls 2.5x135mm AO Drills Due to Material Concerns
Zimmer GmbH is recalling 2.5x135mm AO Drills because they may be made from a different material than specified. The products were distributed to 41 US states.
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 and involves a medical device with a potential material defect. No injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling Drill, 2.5x135mm, AO, Item Number 502015142. 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 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. All items marked with "Normed" are affected.
Consumers and healthcare facilities should stop using the affected products and contact Zimmer GmbH for further instructions.
The recalled product
- Product
- Drill, 2.5x135mm, AO, Item Number 502015142
- 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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