The Recall Desk
ModerateFDA (Devices)·Z-1485-2019·Announced 2019-05-29

Zimmer GmbH Recalls 3.2x145mm AO Drills Due to Material Concerns

Zimmer GmbH is recalling specific AO drills because they may have been manufactured from a different material than specified.

What this means for you

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 hospitalizations, injuries, or illnesses. The hazard is a potential material deviation without confirmed harm, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer GmbH is recalling Drill, 3.2x145mm, AO, Item Number ST502015650. 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 hospitals and medical facilities in 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 should stop using the affected drills and contact Zimmer GmbH for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
Drill, 3.2x145mm, AO, Item Number ST502015650
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 →