Z-0209-2025 Class II Ongoing
FDA device recall Z-0209-2025 was initiated by Blue Ortho on August 30, 2024 and is designated Class II. Reason for recall: Predict+ is being recalled for lack of pre-market clearance/approval. The recall status is ongoing. Affected quantity: 136 software units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- August 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 software units
Product Description
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Reason for Recall
Predict+ is being recalled for lack of pre-market clearance/approval.
Distribution Pattern
US Nationwide distribution.
Code Information
Software version v1.3