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Aju Pharm Co., Ltd. recalls

The FDA has posted 8 enforcement recalls from Aju Pharm Co., Ltd. since 2025, none of them Class I (most serious). Most recent report: Feb 4, 2026.

Class II: 8
Class IIOngoingZ-1173-2026

Aju Pharm Co., Ltd. recalls AlternatiV+ Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1171-2026

Aju Pharm Co., Ltd. recalls Genesis Push-In Suture Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1167-2026

Aju Pharm Co., Ltd. recalls Fixone Biocomposite Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1166-2026

Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1170-2026

Aju Pharm Co., Ltd. recalls Genesis Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1172-2026

Aju Pharm Co., Ltd. recalls AlternatiV+ Max Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1169-2026

Aju Pharm Co., Ltd. recalls Genesis Dual Thread Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026
Class IIOngoingZ-1168-2026

Aju Pharm Co., Ltd. recalls Genesis Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

  • Soft Tissue Biodegradable Fixation Fastener
  • Nonconforming Material/Component
Aju Pharm Co., Ltd.Feb 4, 2026

Firm name as filed with the FDA: “Aju Pharm Co., Ltd.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.