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Open, Classified

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

FDA Recall Z-1821-2024 · Posted 2024-05-14

Recalling FirmMedartis Inc.
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2024-04-12
Product Quantity110 units

Reason for Recall

Screw is 16mm long instead of 22mm long.

Firm Action

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 [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091479APTUS FOOT SYSTEMMedartis AG · 2009-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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