Recall Z-1821-2024
Medartis Inc. · initiated April 12, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Codes / lots: Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Reason for recall
Screw is 16mm long instead of 22mm long.
FDA-determined 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.
Details
- Recall number
- Z-1821-2024
- Initiated
- April 12, 2024
- Posted by FDA
- May 14, 2024
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 110 units
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
- Recalling firm
- Medartis Inc., Warsaw, IN