Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable 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 medical device) where a breach of the sterile barrier could lead to infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK) absorbable suture anchors, Product Number 72202631. The recall involves 263,874 units distributed nationwide and to multiple foreign countries. The affected batch numbers are 2012720, 2024445, 2052779, and 2055899.
The recall was initiated because the product packaging may have an improper or incomplete seal on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch.
Healthcare providers and facilities should check their inventory for the specific product number and batch numbers listed above. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.
The recalled product
- Product
- TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Surgical Suture
- Affected units
- 263,874
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)
- Batch Numbers: 2012720 2024445 2052779 2055899
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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