Zimmer GmbH Recalls Stryker 26mm Drill Due to Material Concerns
Zimmer GmbH is recalling Stryker 26mm drills because they may be made from the wrong material. The products were distributed to 39 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 3/5 (High).
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.
Plain-English summary
Zimmer GmbH is recalling Stryker 26mm stop drills (Item Number 502015145) because an investigation found they may have been manufactured from a material different from the specifications required. The recall is classified as Class II by the FDA.
The affected products were distributed to 39 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, and Texas. All items marked with "Normed" are affected by this recall.
Healthcare providers and facilities should stop using these specific drills and contact Zimmer GmbH for instructions on how to return or replace the products.
The recalled product
- Product
- Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
- Manufacturer
- Zimmer GmbH
- Hazard
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.
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