Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter Recalled for Sterility Breach
Smith & Nephew is recalling 563 TWINFIX QUICK-T Knot Pusher Suture Cutters because the sterile packaging may be breached.
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 with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 563 units of the TWINFIX QUICK-T Knot Pusher Suture Cutter, Part Number 7209417, intended for arthroscopic use. The recall is due to the possibility that the sterile packaging of the devices may be breached.
The affected devices were distributed worldwide, including in the United States, Austria, Australia, Germany, France, the United Kingdom, Japan, Portugal, and Russia. The specific batch numbers involved are 50412843, 50477278, and 50527184.
Healthcare providers and facilities should check their inventory for these specific part and batch numbers. If the sterile packaging is compromised, the devices should not be used. Smith & Nephew is the recalling firm responsible for this action.
The recalled product
- Product
- Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 563
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)
- Batch numbers: 50412843
- 50477278
- 50527184
Distribution
Distributed nationwide across the United States.
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