TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Reported: February 26, 2020 Initiated: December 30, 2019 #Z-1273-2020
Product Description
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Reason for Recall
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units
- Distribution
- Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.. Recalled by Smith & Nephew, Inc.. Units affected: 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1273-2020.
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