The Recall Desk
HighFDA (Devices)·Z-1448-2019·Announced 2019-05-29

Zimmer GmbH Recalls V-TEK IVP Step Drills Due to Material Concerns

Zimmer GmbH is recalling V-TEK IVP step drills because an investigation found they may be made from a different material than specified.

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 hazard involves a potential material defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer GmbH is recalling V-TEK IVP step drills, item number 502015637, due to a potential material defect. 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 medical devices were distributed to healthcare facilities in 38 US states, including Alabama, Arizona, California, Florida, New York, and Texas.

Consumers and healthcare providers should stop using the affected step drills and contact Zimmer GmbH for further instructions on the recall.

The recalled product

Product
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
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 →