The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1422-2019·Announced 2019-05-29

Zimmer GmbH Recalls 2.5x87mm AO Drills Due to Material Concerns

Zimmer GmbH is recalling specific AO drills because they may be made from the wrong material. The products 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential material deviation without confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer GmbH is recalling Drill, 2.5x87mm, AO, Item Number 502015137. 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 are marked with "Normed". These items 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.

Consumers and healthcare providers should stop using these products and contact Zimmer GmbH for further instructions.

The recalled product

Product
Drill, 2.5x87mm, AO, Item Number 502015137
Manufacturer
Zimmer GmbH

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.

See all 76 products in this recall →

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