The Recall Desk
HighFDA (Devices)·Z-1470-2019·Announced 2019-05-29

Zimmer GmbH Recalls 2.7mm AO Surgical Drills Due to Material Concerns

Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may be made 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 source text explicitly states no illnesses or injuries have been reported, limiting the score to 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Zimmer GmbH is recalling the Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208. An investigation identified that these products were possibly manufactured from a different material than defined in the applicable specifications. The recall is classified as Class II by the U.S. Food and Drug Administration.

The affected products are identified by the code "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.

Healthcare facilities and consumers should stop using the affected drills and contact Zimmer GmbH for further instructions or a replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208
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 →