APTUS TriLock Screw (Medartis) – incorrect length (2024)
Screw length discrepancy can potentially impact medical device installation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Brand
Medartis Inc.
Lot Codes / Batch Numbers
Part No. A-5850.22/1, UDI-DI: 76300378022PA, Lot No. 24377397.
Products Sold
Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Medartis Inc. is recalling APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation due to Screw is 16mm long instead of 22mm long.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Screw is 16mm long instead of 22mm long.
Recommended Action
Per FDA guidance
Consignees were sent an "URGENT: Field Safety Notice" via email and printed letter, dated 4/12/2024, notifying them of this recall event. Consignees are asked to locate and quarantine affected devices, coordinate the return of affected devices to their distributor, inform all users of the device of this recall event, and return the provided Customer Reply form with the relevant information. Customers with any questions can call Medartis at 574-241-6531 between 7:30 AM and 6:30 PM EST, Monday through Friday. Questions can also be sent via email to Complaints.US@Medartis.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026