Smith & Nephew Recalls TwinFix Ti Suture Anchors Due to Sterility Risk
Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube failure may have breached 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 (sterility breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling the TwinFix Ti 2.8 mm HS Suture Anchor, a fixation device intended to provide secure attachment of soft tissue to bone. The recall involves 325 units distributed in the United States and internationally.
The recall was initiated due to a potential sterile barrier breach. A complaint indicated that the protective tube of the device came off inside the pouch, allowing the pointed end of the device to puncture the package. This breach could affect the sterility of the device.
Affected units are identified by batch numbers 2010547, 2025137, 2036695, 50763859, and 50773071, with Part Number 72200796 and UDI 10600147. The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
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: 2010547
- 2025137
- 2036695
- 50763859
- & 50773071. Part Number 72200796. UDI 10600147.
Distribution
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