APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
This recall is currently active, issued May 14, 2024. It was issued by Medartis Inc..
- Company
- Medartis Inc.
- Recall Initiated
- April 12, 2024
- Posted
- May 14, 2024
- Recall Number
- Z-1821-2024
- Quantity
- 110 units
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Screw is 16mm long instead of 22mm long.
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Lot / Code Info
Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Root Cause
Process control
Action Taken
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.