Device product
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Z-2965-2018
Product summary
- Event
- Event 80731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-2965-2018
Official wording
Reason: A size 22mm threaded peg was found in the package of a 10mm unit.
Code information: Lot 969440; UDI (01)00887868012310(17)280309(10)969440
Distribution pattern: International Distribution to countries of: Japan and Netherlands.
Derived failure modes
-
Unknown
A size 22mm threaded peg was found in the package of a 10mm unit.