Recall Z-1214-2019

Reason for recall

The bone screw is shorter than the intended design specification.

FDA-determined cause: Component design/selection

Action taken

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 utilized the Hex Cortical Screws, 4.0mm that is the subject of this recall, then the customer is to: o Review customer inventory (including any kits that you have prepared for surgical operation) to see if they have any of the impacted product. o If a customer does have impacted product within its inventory, remove the product from use. o Review customer records to see if the impacted product was implanted. If the customer has records that impacted product was implanted, the customer should apply medical judgment to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. o Return to TriMed a return response card by 11 April 2019. Please email the response to: quality@trimedortho.com. Please contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221 or Email: quality@trimedortho.com * Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays).