Synthes Electric Pen Drive Hand Switch Labeling Error Recall
Synthes, Inc. is recalling 249 Electric Pen Drive systems because the Hand Switch labels for 'on' and 'lock' 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 source text identifies the issue as a labeling error where 'on' and 'lock' labels were interchanged. This fits the rubric criterion for 'Minor labeling errors' or 'voluntary precautionary recalls' where no specific injuries are reported in the text.
Plain-English summary
Synthes, Inc. is recalling 249 units of the Synthes Electric Pen Drive (EPD) System. The recall was initiated in May 2013 due to complaints that the Hand Switch for the Electric Pen Drive was not labeled correctly.
The specific defect involves the 'on' and 'lock' labels on the Hand Switch being interchanged. The affected units are identified by Part Number 05.001.012 and Lot Numbers AV18166, AV19044, and AV20666. These products were distributed nationwide.
The Synthes Electric Pen Drive is a medical device indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in various surgical procedures. Users should stop using the affected Hand Switches and contact the recalling firm for instructions.
The recalled product
- Product
- Synthes Electric Pen Drive (EPD) System, 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 surgical procedures, including…
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 249
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)
- Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666
Distribution
Distributed nationwide across the United States.
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