Recall Z-1821-2024 ยท HWC Screw, Fixation, Bone
Medartis Inc.
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
| Date | May 14, 2024 (initiated Apr 12, 2024) |
| Status | Open, Classified |
| Reason | Screw is 16mm long instead of 22mm long. |
| Root cause | Process control |
| 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 Complaints.US@Medartis.com. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091479 | APTUS FOOT SYSTEM Medartis AG, Jul 13, 2009 |