Zimmer GmbH Recalls Cannulated Orthopedic Drills Due to Material Concerns
Zimmer GmbH is recalling specific cannulated orthopedic drills because an investigation found they 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 2/5 (Moderate).
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, which typically indicates a risk of temporary or medically reversible health consequences. The source text describes a potential material deviation without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer GmbH is recalling specific cannulated orthopedic drills (Item Number 502015623) 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 identified by the marking "Normed". These items were distributed to hospitals and medical facilities in 38 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, and Texas.
Consumers and healthcare providers should stop using the affected drills immediately and contact Zimmer GmbH for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Drill, cannulated, 2x95mm, AO, Item Number 502015623
- 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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