Z-1214-2019Class II

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle...

Name: Z-1214-2019 TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle...
Creator: TriMed Inc.
Published: 2018-08-24
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-08-24 / Terminated / root cause: design

FDA source

TriMed Inc. began a recall of 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... on 2018-08-24. FDA classified it as Class II and gives the reason as "The bone screw is shorter than the intended design specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1214-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Posted: 2019-04-23
Terminated: 2020-12-28
Recalling firm: Trimed Inc
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The bone screw is shorter than the intended design specification.
Root cause tag: design
FDA 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 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).
Quantity in commerce: 13 screws
Distribution: US Distribution to states of FL and MO.
Product codes and lots: Lot #170281, UDI (01)00842188107108(11)170406(10)170281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1214-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1214-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23

Product code HRS

K060041Class IITrimed Bone PlatesTriMed, Inc. / cleared 2006-02-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)