Recall Z-1214-2019 ยท HRS Plate, Fixation, Bone
TriMed Inc.
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, S
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | The bone screw is shorter than the intended design specification. |
| Root cause | Component design/selection |
| Action | The recalling firm, TriMed, issued a "URGENT MEDICAL DEVICE RECALL" letter via email on 8/24/2018 to the distributors and third-party distributor. A follow-up letter was issued 3/28/2019 requesting downstream customers be notified to the user level. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If the customer further distributed Hex Cortical Screws, 4.0mm that is the subject of this recall, to forward the letter and the return response card to those entities that utilized the impacted product. " If the customer utilize |
| Quantity | 13 screws |
| Distribution | US Distribution to states of FL and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060041 | TRIMED BONE PLATES TriMed, Inc., Feb 7, 2006 |