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.
What this means for you
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 is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK absorbable suture anchors (Product Number 72202624). The recall involves 263,874 units distributed nationwide and to numerous foreign countries.
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.
Affected batch numbers include 2013904, 2018628, 2023177, 2025213, 2039590, 2050959, and 2052719. Healthcare providers and facilities should check their inventory for these specific product numbers and batch numbers.
The recalled product
- Product
- TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
- Manufacturer
- Smith & Nephew, Inc.
- 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: 2013904 2018628 2023177 2025213 2039590 2050959 2052719
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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