Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
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 risk-of-harm product (sterile breach leading to potential infection) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without confirmed harm.
Plain-English summary
Smith & Nephew, Inc. is recalling specific batches of the ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors (Product Number: 72201493). The recall is due to improper or incomplete seals on the product packaging pouches, which may result in a breach of the sterile barrier surrounding the device.
The affected batch numbers are 2024948, 2024949, 2027356, 2029176, and 2044635. The products were distributed nationwide and in numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
Healthcare providers and patients should check their inventory and records for these specific batch numbers. If the sterile barrier is compromised, the device may not be sterile, posing a risk of infection if used. Users should stop using these specific units and contact Smith & Nephew for further instructions.
The recalled product
- Product
- ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
- Manufacturer
- Smith & Nephew, Inc.
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 (5)
- Batch Numbers: 2024948
- 2024949
- 2027356
- 2029176
- 2044635
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Smith & Nephew, Inc. 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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