GRYPHON ORTHOCORD 210813Recalls & reported problems
Medos International Sàrl · GRYPHON P BR DS Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) · Class 2 · Implant
All models of GRYPHON ORTHOCORD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Gryphon OrthoCord suture anchor has 698 adverse event reports, with no deaths and 39 injuries. Many describe the anchor breaking, cracking or pulling out during arthroscopic procedures such as knee and ligament repair, with surgeons removing broken parts and using another device to finish. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 712
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 712 adverse event reports that list this exact device (DI 10886705001279), received between Feb 21, 2018 and Sep 30, 2026 — classified as 39 injuries, 673 malfunctions.
The most frequently reported specific device problem is “Break” (509 reports).
7 other recalls cover devices cleared under the same FDA submission (K090124, K150209); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break509
- Migration92
- Migration or Expulsion of Device25
- Crack21
- Detachment of Device or Device Component21
- Difficult to Advance16
- Adverse Event Without Identified Device or Use Problem12
- Device Damaged Prior to Use11
Patient problems
- No Clinical Signs, Symptoms or Conditions525
- No Consequences Or Impact To Patient136
- Injury17
- Not Applicable13
- Unspecified Tissue Injury13
- No Known Impact Or Consequence To Patient8
- No Code Available7
- Tissue Damage4
Recent adverse event reports
The 25 most recent of 712 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949210 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948903 ↗MalfunctionSep 29, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933733 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923844 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923444 ↗MalfunctionSep 28, 2026Break; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917257 ↗MalfunctionSep 25, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903504 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880986 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another GRYPHON ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880983 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873558 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872626 ↗MalfunctionSep 23, 2026Break
It was reported that during an unspecified arthroscopic procedure the GRYPHON P BR DS ANCHOR W/OC anchor device broke on insertion. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869040 ↗MalfunctionSep 23, 2026Break
It was reported that during a labral repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another two GRYPHON ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 3 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866109 ↗MalfunctionSep 23, 2026Break
It was reported that during a labral repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another two GRYPHON ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866107 ↗MalfunctionSep 23, 2026Break
It was reported that during a labral repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another two GRYPHON ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866102 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another GRYPHON ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865714 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another GRYPHON ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865711 ↗MalfunctionSep 22, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another GRYPHON ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857291 ↗MalfunctionSep 22, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another GRYPHON ORTHOCORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857286 ↗MalfunctionSep 18, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821719 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780671 ↗MalfunctionSep 15, 2026Break
It was reported that during an unspecified procedure, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769426 ↗MalfunctionSep 11, 2026Break
It was reported that the event occurred during a knee arthroscopy surgery and it involved two devices. Firstly, when the suture of a RIGIDLOOP device was tightened, the suture broke off. Another device was used to complete the surgery. Second, a GRYPHON ORTHOCORD anchor broke off. All the broken parts were removed. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50729036 ↗MalfunctionSep 9, 2026Break
It was reported that during a Shoulder arthroscopy procedure, the GRYPHON ORTHOCORD anchor was broken off. All the broken parts were removed. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688592 ↗MalfunctionSep 1, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545912 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090124, K150209. One submission often covers many models, so check the product and lot details in each record.
- Z-1679-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
- Z-1678-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
- Z-1680-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
- Z-1677-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
- Z-1681-2023 · Apr 13, 2023 · Open, ClassifiedDePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
- Z-2210-2011 · Feb 24, 2011 · TerminatedDePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic
- Z-2211-2011 · Feb 24, 2011 · TerminatedDePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bicep
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
- Arthrex® AR-1927BCF-45Arthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE164 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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