Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.
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 required sterility assurance levels, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Greatbatch Medical has initiated a global field recall for 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 steam sterilization cycles described in the Instruction For Use (IFU).
The affected products are non-sterile torque limiting attachments distributed by Zimmer and PRECIMED. The recall covers 5,952 units distributed in the United States (Indiana, Michigan, Texas) and internationally (Germany, France, Italy, Switzerland). Specific customer numbers and model codes are listed in the recall documentation.
Healthcare providers and facilities should stop using the affected devices and contact Greatbatch Medical for further instructions on the recall process.
The recalled product
- Product
- Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003…
- Manufacturer
- Greatbatch Medical
- Affected units
- 5,952
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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