Zimmer GmbH Recalls 26mm Orthopedic Drills Due to Material Concerns
Zimmer GmbH is recalling 26mm orthopedic drills that may have been manufactured from a different material than specified.
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 involves a medical device with a potential material defect that could compromise safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer GmbH is recalling specific 26mm orthopedic drills (Item Number 502015124) 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 distributed across 40 US states, including Alabama, Arizona, California, Florida, New York, and Texas. All items marked with "Normed" are affected by this recall.
Healthcare providers and consumers should stop using the affected drills immediately and contact Zimmer GmbH for further instructions on return or replacement.
The recalled product
- Product
- Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
- 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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