Device product
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
Z-0470-2018
Product summary
- Event
- Event 78763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 638 units
- Official record key
device-enforcement:Z-0470-2018
Official wording
Reason: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Code information: Item No. 814511420; Lot No. (Exp. Date) UDI: 535130 (06/02/2027) UDI (01)00887868039195 (17)270602 (10)535130; 858960 (06/15/2027) UDI (01)00887868039195 (17)270615 (10)858960
Distribution pattern: US nationwide distribution. Also Portugal and the Netherlands.
Derived failure modes
-
Unknown
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.