Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure
Greatbatch Medical is recalling torque limiting handles 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 involves a medical device that fails to achieve required sterility levels, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Greatbatch Medical has initiated a global field recall for specific Torque Limiting Devices, including PRECIMED T-Handle Torque, Non Sterile handles. The recall involves two units of the device.
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). This failure means the devices may not be sterile when used as intended.
The affected units were distributed in the United States (Indiana, Michigan, Texas) and internationally (Germany, France, Italy, Switzerland). Users should stop using these devices and contact Greatbatch Medical for further instructions.
The recalled product
- Product
- Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
- Manufacturer
- Greatbatch Medical
- Affected units
- 2
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)
- 6307760001
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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