Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: N
FDA device recall Z-1550-2026 · posted 2026-03-10 · Open, Classified
Recall details
- Recalling firm
- Medartis AG
- Reason for recall
- Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Action taken
- Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 126
- Distribution
- Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Jap
- Date initiated
- 2026-01-09
- Date posted
- 2026-03-10
- Location
- Basel Town, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APTUS FOOT SYSTEM (K091479) | Medartis AG | 2009-07-13 |