Device product
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Z-0544-2014
Product summary
- Event
- Event 66698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 Devices
- Official record key
device-enforcement:Z-0544-2014
Official wording
Reason: During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Code information: Lot/Serial Numbers: 357305-000
Distribution pattern: US Distribution to VA and TX.
Derived failure modes
-
Unknown
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.