Zimmer GmbH Recalls 19mm Orthopedic Drills Due to Material Concerns
Zimmer GmbH is recalling specific 19mm orthopedic drills because they may be made from the wrong material. The devices were distributed to 38 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a potential material defect in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer GmbH is recalling specific 19mm orthopedic drills (Item Number 502015131) due to a potential manufacturing defect. An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products are 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.
Healthcare facilities and consumers should stop using these devices and contact Zimmer GmbH for instructions on return or replacement.
The recalled product
- Product
- Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
- 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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