Stryker Farabeuf Clamp Recalled for Incorrect Laser Etching on Lever Arm
Stryker GmbH is recalling Farabeuf Clamps for 3.5mm Screws PRO because laser etching indicating compression or distraction mode is on the wrong side of the lever arm.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a labeling error (mis-etching) which fits the criteria for moderate severity involving minor labeling errors or low-risk issues without reported harm.
Plain-English summary
Stryker GmbH is recalling 18 Farabeuf Clamps for 3.5mm Screws PRO, Catalog # 705463, Lot # 04857V. The recall involves 10 parts that were quarantined and 8 parts that were distributed to facilities in Arkansas, California, Idaho, Illinois, Maryland, Michigan, New Jersey, New York, Oklahoma, South Dakota, and Texas.
The recall was initiated because the laser etching that indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm. This labeling error could potentially lead to incorrect usage of the surgical instrument.
Healthcare facilities that received these devices should stop using them and contact Stryker GmbH for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
- Manufacturer
- Stryker 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)
- Lot # 04857V
Distribution
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