FDA Medical Device Recalls (openFDA)
Aju Pharm Co., Ltd.: Genesis Screw-In Anchor
- Recall number
- Z-1168-2026
- Recalling firm
- Aju Pharm Co., Ltd.
- Product
- Genesis Screw-In Anchor
- Status
- Open, Classified
- Initiated
- 2025-12-17
- Posted
- 2026-01-26
- Terminated
- not on file
- Reason
- Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Root cause
- Nonconforming Material/Component
- Action
- An 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
- 600 units
- Distribution
- US Nationwide distribution in the states of CA & PR.
- Lot, serial or model codes
- Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
- 510(k) numbers
- ["K193497","K203523","K222423","K230892","K233601"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 3014232239
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28