Medartis AG recalls Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm
Reason for recall
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 applicableModel A-5750.16/16 affected lotsA-5750.16/12.516mmHD71/Pkg25472432
What the firm is doing
Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
DistributionShow detailsHide
Worldwide - 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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1549-2026
- FDA 510(k) clearance · K051567The device's official FDA premarket clearance record
- FDA device classification · HWCOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3040The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medartis AGSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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