Z-1172-2026 Class II Ongoing
FDA device recall Z-1172-2026 was initiated by Aju Pharm Co., Ltd. on December 17, 2025 and is designated Class II. Reason for recall: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. The recall status is ongoing. Affected quantity: 2,569 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,569 units
Product Description
AlternatiV+ Max Knotless Anchor
Reason for Recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Distribution Pattern
US Nationwide distribution in the states of CA & PR.
Code Information
Model No. 20KPN4751, 20KPN5501; All UDI Codes; All Lots.