Summary
The FDA issued a Class II for Genesis Dual Thread Screw-In Anchor by Aju Pharm Co., Ltd.. Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage..
Details
Source
Device Recall
External ID
Z-1169-2026
Action Date
2026-02-04
Status
Ongoing
Category
device
Product Description
Genesis Dual Thread Screw-In Anchor
Lot/Code Info: Model No. 10N47502, 10N55002; All UDI Codes; All Lots.
Quantity Affected: 400 units
Reason for Recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Distribution
US Nationwide distribution in the states of CA & PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-17
Company
Seongnam, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aju Pharm Co., Ltd. has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aju Pharm Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aju Pharm Co., Ltd. have FDA actions?
Aju Pharm Co., Ltd. has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1169-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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