Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to achieve the required sterility assurance level, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, placing it in the High severity category per the rubric.
Plain-English summary
Greatbatch Medical has initiated a global field recall for its torque limiting devices. The recall was initiated after laboratory testing revealed that the devices do not achieve the required sterility assurance level (SAL) of 10-6 when subjected to the steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
The affected products include torque limiting screwdrivers manufactured by Greatbatch Medical, PRECIMED, and Zimmer. These devices are non-sterile and prescription-only. The recall covers 1,110 units distributed in the United States (Indiana, Michigan, Texas) and internationally (Germany, France, Italy, Switzerland).
Healthcare facilities and consumers should stop using these devices and contact Greatbatch Medical for further instructions on the recall.
The recalled product
- Product
- Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506…
- Manufacturer
- Greatbatch Medical
- Affected units
- 1,110
Distribution
Part of a larger recall action
This product is one of 3 recalled by Greatbatch Medical 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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