[pending] Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Sc
Pending LLM rewrite. Source: FDA_DEVICE Z-2361-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The cannulation of the CCS screw is not centered.
The recalled product
- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Manufacturer
- Medartis AG
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 07630037887706
- Lot Numbers: 25444702
- 24425542
- 24404471
- 25441997
Distribution
Distributed nationwide across the United States.
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