Device product
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Z-1273-2020
Product summary
- Event
- Event 84748
- Status
- Terminated
- Classification
- Class II
- 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
- Official record key
device-enforcement:Z-1273-2020
Official wording
Reason: 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.
Code information: Batch numbers: 2010547, 2025137, 2036695, 50763859, & 50773071. Part Number 72200796. UDI 10600147.
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
sterile barrier breach