Zimmer GmbH Recalls 3.5mm Orthopedic Drill Due to Material Concerns
Zimmer GmbH is recalling specific 3.5mm orthopedic drills because they may have been manufactured from a different material than specified.
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 involves a medical device with a potential material defect that could compromise performance, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling the Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216. 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 or a replacement.
The recalled product
- Product
- Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
- 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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