Device product
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.
Z-1214-2019
Product summary
- Firm
- TriMed Inc.
- Event
- Event 82209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 screws
- Official record key
device-enforcement:Z-1214-2019
Official wording
Reason: The bone screw is shorter than the intended design specification.
Code information: Lot #170281, UDI (01)00842188107108(11)170406(10)170281
Distribution pattern: US Distribution to states of FL and MO.
Derived failure modes
-
Unknown
The bone screw is shorter than the intended design specification.