FDAClass IIMay 22, 2024

APTUS 2.8 TriLock Screw 22mm recall

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Why was APTUS 2.8 TriLock Screw 22mm recalled?

Screw is 16mm long instead of 22mm long.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.

Product
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Recalling firm
Medartis Inc.
Quantity
110 units
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Recall date
May 22, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls