Greatbatch Medical Recalls 45 Degree Angle Drivers for Noisy Operation
Greatbatch Medical is voluntarily recalling 913 Small Angled Driver 45 units worldwide due to reports of noisy or rough operation.
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 a voluntary precautionary measure for a mechanical performance issue (noisy/rough operation) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45 product line. The recall involves 913 units of the 45 Angle Driver / Z-H, which is intended to act as an interface between a cutting tool and a motorized driving system, such as a surgical drill.
The recall was initiated after Greatbatch received reports of noisy and/or rough operation when using these devices. The affected models include P2661, P2662, T3635, T5586, T6031, T6164, T10161, T12628, T14879, T16422, T2487, T2713, T116057, T13635, MPU260045AO01, and MPU260045ZH01.
The affected units were distributed worldwide, including in the United States (CA, IN, KS, MA, NJ, PA, TN, and TX) and in Australia, Brazil, Canada, Denmark, France, Germany, Italy, Japan, Portugal, and Switzerland. All lots are affected. The source text does not specify specific consumer actions or report any injuries or illnesses associated with the defect.
The recalled product
- Product
- 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface…
- Manufacturer
- Greatbatch Medical
- Hazard
- Affected units
- 913
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 lots
Distribution
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