The Recall Desk
ModerateFDA (Devices)·Z-1437-2019·Announced 2019-05-29

Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

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 illnesses, injuries, or hospitalizations. The hazard is a potential material deviation without confirmed adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer GmbH is recalling Drill, cannulated, 2x95mm, round shaft, Item Number 502015619. 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 identified by the code "Normed". These items were distributed to 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.

Healthcare providers and facilities should stop using the affected devices and contact Zimmer GmbH for further instructions regarding the return or replacement of the products.

The recalled product

Product
Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
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 →