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TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40… recallZ-1214-2019 · TriMed Inc. · initiated Aug 24, 2018

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TriMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The bone screw is shorter than the intended design specification.

FDA root cause category: Component design/selection

What the company is doing

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: [email protected]. Please contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221 or Email: [email protected] * Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays).

Recall details

Recall number
Z-1214-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 24, 2018
Recalling firm
TriMed Inc.
Quantity
13 screws
Product code
HRS
FDA submissions
K060041
Distribution
US Distribution to states of FL and MO.

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.

Code information (models, lots, serial numbers)

Lot #170281, UDI (01)00842188107108(11)170406(10)170281

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K060041 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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