Fastener, Fixation, Biodegradable, Soft Tissue
Orthopedic · 21 CFR 888.3030
Recent MDR events
17,071 adverse event reports on file
- MILAGROJul 31, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03386
- SUTR ANCH,BIO-COMP S-TAKJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04133
- BIO-COMP SWVLK C, CLD 4.75X19.1MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04134
- BIO-COMP SWVLK C, CLD 4.75X19.1MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04135
- SUTR ANCH,BIO-COMP S-TAKJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04136
- BIO-COMPSI CRKSCRW FT 4.5X 14MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04137
- SUTR ANCH,BIO-COMP S-TAKJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04139
- SUTR ANCH,BIO-COMP S-TAKJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04140
- HEALIX ADVANCE ORTHOCORDJul 31, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03393
- PEEK SWIVELOCK C,4.75x19.1MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04144
Event type breakdown
Recalls
96 recall events for this product code
- Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Fixone Hybrid Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1166-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Fixone Biocomposite Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1167-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Genesis Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1168-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1169-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Genesis Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1170-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1171-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
AlternatiV+ Max Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1172-2026 · View FDA record ↗ - Aju Pharm Co., Ltd.Open, ClassifiedJan 26, 2026
AlternatiV+ Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1173-2026 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.Open, ClassifiedJun 2, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
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
Z-1677-2023 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.Open, ClassifiedJun 2, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization
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
Z-1678-2023 · View FDA record ↗
Registered firms
1,208 firms currently registered for this product code
Arthrex, Inc.
Naples, FL, US
Ethicon, Inc.
CIUDAD JUAREZ Chihuahua, MX
Ortosistemas, S.a.
Panama, PA
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Arthrex Chile Spa
Pudahuel Region Metropolitana, CL
Arthrocare Corporation
Coyol Alajuela, CR
Arthrex Manufacturing Inc.
Pendleton, SC, US
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Sterigenics U.s., Llc
Atlanta, GA, US
Arthrex, Inc.
Ave Maria, FL, US
Sterigenics Us, Llc
Lewis Center, OH, US
Arthrex New Zealand Limited
Auckland, NZ
Biotec Biotecnologias De Centroamerica S.a.
Rohrmoser San Jose, CR
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Riverpoint Medical Llc
Portland, OR, US
510(k) clearances
221 clearances for this product code
- Arthrex, Inc.Aug 7, 2026
K262357 · Arthrex Bioabsorbable PushLock Suture Anchors
- Arthrex, Inc.May 28, 2026
K253931 · Arthrex Bioabsorbable PushLock Suture Anchors
- Surgical Fusion Technologies GmbHMar 27, 2026
K260294 · SF Push-in Anchor
- OSSIO , Ltd.Feb 24, 2026
K254055 · OSSIOfiber® Suture Anchor
- Biocomposites, Ltd.Feb 17, 2026
K251680 · Biosteon® Screw
- Conmed CorporationOct 15, 2025
K252946 · BioBrace® Extra-Articular Ligament Augmentation Kit
- OSSIO , Ltd.Aug 19, 2025
K252022 · OSSIOfiber® Interference Screw
- OSSIO , Ltd.May 27, 2025
K251309 · OSSIOfiber® Suture Anchor