Fastener, Fixation, Biodegradable, Soft Tissue
FDA adverse event reports and recall history for fastener, fixation, biodegradable, soft tissue (product code MAI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 16,825
- Deaths
- 0
- Injuries
- 4,074
- Malfunctions
- 12,342
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Fixone Hybrid Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Fixone Biocomposite Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Genesis Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Genesis Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
AlternatiV+ Max Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2026-01-26Open, ClassifiedNonconforming Material/Component
AlternatiV+ Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 2023-06-02Open, ClassifiedUse error
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
- 2023-06-02Open, ClassifiedUse error
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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