Z-1171-2026Class II

Genesis Push-In Suture Anchor

Name: Z-1171-2026 Genesis Push-In Suture Anchor
Creator: Aju Pharm Co., Ltd.
Published: 2025-12-17
License: https://open.fda.gov/license/

Aju Medical Co., Ltd. / initiated 2025-12-17 / Open, Classified / root cause: manufacturing process

FDA source

Aju Pharm Co., Ltd. began a recall of Genesis Push-In Suture Anchor on 2025-12-17. FDA classified it as Class II and gives the reason as "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1171-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-17
Posted: 2026-01-26
Recalling firm: Aju Medical Co., Ltd.
Product: Genesis Push-In Suture Anchor
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 200 units
Distribution: US Nationwide distribution in the states of CA & PR.
Product codes and lots: Model No. 10S30002; All UDI Codes; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1171-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1166-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1167-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1168-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1169-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1170-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1171-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1172-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26
Z-1173-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-26

Product code MAI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)