TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A recall: Sterility Concern
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Why was TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.
- Product
- TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 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.
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)