Z-1214-2019 Class II Terminated
FDA device recall Z-1214-2019 was initiated by TriMed Inc. on Aug 24, 2018 and is designated Class II. Reason for recall: The bone screw is shorter than the intended design specification. The recall status is terminated (terminated Dec 28, 2020). Affected quantity: 13 screws.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- Aug 24, 2018
- Termination Date
- Dec 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 screws
Product Description
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.
Reason for Recall
The bone screw is shorter than the intended design specification.
Distribution Pattern
US Distribution to states of FL and MO.
Code Information
Lot #170281, UDI (01)00842188107108(11)170406(10)170281
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1214-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026