INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled
Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.
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: This is an FDA Class II recall of a medical device with risk of malfunction. Although no injuries or illnesses have been reported, the potential for assembly failure in a medical context constitutes a risk-of-harm product, which per the severity rubric scores as High (3).
Plain-English summary
Smith & Nephew, Inc. is recalling INTEGRA SURFIX ALPHA Screwdriver Torx 10 medical device units (REF 219 135 ND) because the affected screwdrivers are out of specification and may not mate properly with the Surfix Alpha Lock screw.
The recall affects 8 units distributed in California and Ohio. The affected batch numbers are FTL9, FTLA, and FVRG. The product UDI is (01)10381780052234 (11)21101 (10)FVRG.
Healthcare facilities and providers should immediately stop using affected screwdrivers from the identified batch numbers. Contact Smith & Nephew for replacement units or disposal instructions. No injuries or illnesses have been reported related to this recall.
The recalled product
- Product
- INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 8
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 (4)
- UDI: (01)10381780052234 (11)21101 (10)FVRG
- Batch Numbers: FTL9
- FTLA
- and FVRG
Distribution
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