Z-2971-2026 Class III Ongoing
FDA device recall Z-2971-2026 was initiated by Paragon 28, Inc. on July 10, 2026 and is designated Class III. Reason for recall: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Reason for Recall
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Distribution Pattern
US Nationwide distribution i the state of MT.
Code Information
Lot Number AOCIA6123