Synthes Electric Pen Drive Hand Switch Recalled for Labeling Error
Synthes USA HQ, Inc. is recalling 290 Electric Pen Drive Hand Switches because the 'on' and 'lock' labels were interchanged.
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, and the hazard is a minor labeling error where labels were interchanged, fitting the rubric for moderate severity.
Plain-English summary
Synthes USA HQ, Inc. is recalling 290 units of the Synthes Hand Switch for the Electric Pen Drive, Part Number 05.001.012, Lot Number AV18166. The recall was initiated after the company received a customer complaint stating that the device was not labeled correctly.
The specific defect involves the 'on' and 'lock' labels being interchanged on the hand switch. The Electric Pen Drive is a medical device indicated for various surgical procedures, including screw insertion, pin and wire replacement, and bone cutting or drilling.
The affected units were distributed nationwide in the United States, as well as internationally to Mexico and Canada. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 290
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 (2)
- Part Number 05.001.012
- lot number AV18166
Distribution
Distributed nationwide across the United States.
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