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 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 the hazard involves a potential material deviation in a medical device. No illnesses or injuries 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 the Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619. The recall was initiated after an investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. All items marked with "Normed" are affected by this recall.
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. The source text does not specify the number of units recalled or the specific dates of distribution.
Healthcare providers and facilities should check their inventory for the specific item number and the "Normed" marking. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate FDA contact as directed by the recall notice.
The recalled product
- Product
- Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
- 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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