Genesis Dual Thread Screw-In Anchor recall (Aju Pharm Co., Ltd.)
Medical deviceClass IIOngoing
Summary: Aju Pharm Co., Ltd. is recalling Genesis Dual Thread Screw-In Anchor. Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
What is being recalled
Genesis Dual Thread Screw-In Anchor
Why
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA & PR. (states named: California, Puerto Rico)
How to tell if yours is affected
Model No. 10N47502, 10N55002; All UDI Codes; All Lots.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1169-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 17, 2025 |
| Reported | February 4, 2026 |
| Company | Aju Pharm Co., Ltd. |
| Company location | Seongnam, N/A, Korea (the Republic of) |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 400 units |
More recalls from Aju Pharm Co., Ltd. · all medical device recalls · recalls from December 2025