Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA PLLA/HA 6.5 W/3 UB Absorbable Suture Anchors (Product Number: 72202610). The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch numbers affected are 2024447 and 2039587.
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, potentially compromising the sterility of the device.
Healthcare providers and facilities should check their inventory for the affected product numbers and batch numbers. 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 PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
- 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: 2024447 2039587
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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