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Recall Observatory FDA recall evidence

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

August 24, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    The bone screw is shorter than the intended design specification.