Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Absorbable Suture Anchors because improper or incomplete packaging seals 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 a breach of the sterile barrier could lead to infection, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Smith & Nephew, Inc. is recalling 263,874 units of TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Absorbable Suture Anchors (Product Number: 72202603). The recall involves specific batch numbers: 2012913, 2024716, 2025341, 2031135, 2033510, 2034402, 2036289, and 2037671.
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. The affected products were distributed nationwide and in numerous foreign countries, including AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP, KR, LV, MY, NL, NO, PA, PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, and ZA.
Healthcare providers and facilities should check their inventory for the affected product number and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.
The recalled product
- Product
- TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 263,874
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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