medical Class II Updated 2020-02-26

Smith & Nephew, Inc. recalls TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixati

Recalled Product

TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

Hazard / Issue

Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.
View official government recall

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