Home/Recalls/FDA-Z-1549-2026
FDA DevicesClass II

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Published: March 18, 2026Recall ID: Z-1549-2026Category: devicesCountry: US
US
Medical DeviceFDA DevicesUSUS

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Recalling Firm: Medartis AG

Reason for Recall / Hazard

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Product Description & Identification

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Affected Products

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Additional Source Details

FieldValue
CityBasel Town
StateN/A
Event id98353
Address 1Hochbergerstrasse 60e
Address 2N/A
Code infoLot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Postal codeN/A
Report date20260318
Product typeDevices
Product quantity0
Reason for recallMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260109
Initial firm notificationLetter
Center classification date20260310

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Overview

  • Recalling FirmMedartis AG
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
Recall Hazard Severity
High Alert (Class I)
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🚨 SAFETY ALERT: Medartis AG - Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

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https://therecallfile.com/recalls/brand-name-aptus-product-name-2-5-trilock-screw-16mm-hd7-1-pkg-model-c/FDA-Z-1549-2026
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Spread the WordBrand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

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