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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis ScrewIn Anchor

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 Class 2 Device Recall Genesis ScrewIn Anchorsee related information
Date Initiated by FirmDecember 17, 2025
Date PostedJanuary 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1168-2026
Recall Event ID 98312
510(K)NumberK193497 K203523 K222423 K230892 K233601 
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
ProductGenesis Screw-In Anchor
Code Information Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Recalling Firm/
Manufacturer		 Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)
Manufacturer Reason
for Recall		Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE RECALL notice dated 12/17/25 was mailed to consignees. The notification instructs consignees to discontinue use of affected devices, segregate affected devices, and return the product to Aju Pharm Medical or the authorized distributor. If product was further distributed the recall notification is to be forwarded for their awareness. Aju Pharm states that no additional action is required for patients who have already undergone surgery using affected devices. Consignees with any questions should contact +82-02-2630-0641 by phone or ajumedi@ajupharm.co.kr.
Quantity in Commerce600 units
DistributionUS Nationwide distribution in the states of CA & PR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MAI
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