Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
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 the hazard involves a potential material deviation in a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling the Drill, cannulated, 4x90mm, round shaft, Item Number 502015640. 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.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these devices.
The recalled product
- Product
- Drill, cannulated, 4x90mm, round shaft, Item Number 502015640
- 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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