APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
FDA device recall Z-1821-2024 · posted 2024-05-14 · Open, Classified
Recall details
- Recalling firm
- Medartis Inc.
- Reason for recall
- Screw is 16mm long instead of 22mm long.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 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.
- Date initiated
- 2024-04-12
- Date posted
- 2024-05-14
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APTUS FOOT SYSTEM (K091479) | Medartis AG | 2009-07-13 |