FDAClass IIMay 1, 2019

TriMed Hex Cortical Screw 4.0 recall

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…

Why was TriMed Hex Cortical Screw 4.0 recalled?

The bone screw is shorter than the intended design specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
TriMed Inc.
Quantity
13 screws
Distribution
US Distribution to states of FL and MO.
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls