Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements
Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.
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: FDA Class II recall of a surgical instrument that cannot meet sterilization requirements. No illnesses or injuries have been reported, making this a potential risk-of-harm scenario where injury has not yet occurred.
Plain-English summary
Tornier, Inc is recalling 1066 units of the Ratcheting Screwdriver Handle (Model MWJ128) included in the Aequalis Perform Reversed surgical kit. The handle is unable to meet sterilization requirements when sterilized using the specified Aesculap container and procedures.
Surgical instruments must be properly sterilized to prevent infection during procedures. A screwdriver handle that cannot achieve required sterilization levels creates a potential infection risk for patients undergoing surgery.
The affected units were distributed nationwide in the United States. If you have received this product, contact Tornier, Inc for instructions on returning the device.
The recalled product
- Product
- Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- Manufacturer
- Tornier, Inc
- Affected units
- 1,066
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 (3)
- Model: MWJ128
- Ratcheting Screwdriver Handle
- all lot codes
Distribution
Distributed nationwide across the United States.
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