Medartis AG: Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. P
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medartis AG
- Product
- Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
- Reason / hazard
- Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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, Japan, and Poland.
- Recall initiated
- 2026-01-09
- Code info
- Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
- Product quantity
- 126
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Basel Town
- State
- N/A
- Country
- Switzerland
- Event id
- 98353
Free daily digest + "My products" watchlist