FASTIN ORTHOCORD 222994Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705008728), received between Jul 20, 2018 and Jul 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041075, K060664); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE FASTIN RC 6.5MM OCORD W/O NDLS ANCHOR DEVICE, THE DEVICE COULD NOT BE INSERTED. A NEW DEVICE WAS USED AND WAS INSERTED WITH NO DIFFICULTY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468751 ↗
• MalfunctionSep 9, 2020Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT TWO ANCHOR DEVICES PULLED OUT OF THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY WITH A COUPLE OF MINUTES DELAY. THERE WAS AN ALTERNATIVE PRODUCT READILY AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10508876 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VIOLET FASTIN RC 6.5 MM ANCHOR, W/ ORTHOCORD - W/O NEEDLES BROKE OFF WHEN USED WITH EXPRESSSEW GUN (W/ NEEDLE INSERTED). IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY USING JUST ONE SUTURE ON THE ANCHOR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812523 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE VIOLET FASTIN RC 6.5 MM ANCHOR, W/ ORTHOCORD - W/O NEEDLES BROKE OFF WHEN WITH EXPRESSSEW GUN (W/ NEEDLE INSERTED). IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING JUST ONE SUTURE OF THE DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812501 ↗
• MalfunctionJul 20, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE TWO ORTHOCORD WIRES WAS BROKEN. IT WAS REPORTED THAT THE PACKAGE WAS JUST OPENED WHEN THE EVENT OCCURRED. IT WAS FURTHER REPORTED THAT THE VIOLET COLORED WIRE ON ALL THREE ANCHORS WERE BROKEN. IT WAS REPORTED THAT THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING JUST THE SUTURE OF THE ANCHOR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707146 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041075, K060664. One submission often covers many models, so check the product and lot details in each record.

• Z-0446-06 · Oct 27, 2005 · Terminated
  Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740