Device product
Genesis Screw-In Anchor
Z-1168-2026
Product summary
- Event
- Event 98312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 600 units
- Official record key
device-enforcement:Z-1168-2026
Official wording
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Code information: Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Distribution pattern: US Nationwide distribution in the states of CA & PR.
Derived failure modes
-
Unknown
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.