FASTIN ORTHOCORD 222991Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886705008698), received between Jul 3, 2017 and Apr 21, 2026 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, THE FASTIN RC 5.0 W/OCORD W/NDLS ANCHOR WAS HANDED TO THE SPECIALIST, AND UPON IMPACT AND SUBSEQUENT THREADING, THE GUIDE ON WHICH THE ANCHOR WAS MOUNTED WAS WITHDRAWN; HOWEVER, THE ATTACHED SUPER-SUTURES WERE FOUND TO BE BROKEN AND TORN, CAUSING THE ANCHOR TO DETACH AND REMAIN LODGED WITHIN THE PATIENT'S BONE, RENDERING THE TITANIUM ANCHOR UNRECOVERABLE. TO RESOLVE THIS ISSUE, A PEEK ANCHOR WAS PROVIDED TO THE PHYSICIAN, ALLOWING THE PROCEDURE TO BE COMPLETED CORRECTLY AND THE SURGERY TO CONCLUDE SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, NOR WERE THERE ANY ALTERATIONS TO THE SURGICAL TIMELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942385 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON INSERTED THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE, IT HIT THE TIP AND THREAD ALIGNED WITH THE SECOND LASER LINE. WHEN ATTEMPTING TO KNOT THE TWO SUTURES THAT WERE PART OF THE ANCHOR, THE SURGEON OBSERVED THAT ONE OF THE SUTURES BROKE. AS A RESULT, IT WAS IMPOSSIBLE TO COMPLETE THE FIXATION SINCE THE ANCHOR WAS DESIGNED TO INCLUDE TWO SUTURES, BUT ONLY ONE REMAINED USABLE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809746 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE, WHEN THE ANCHOR WAS IMPLANTED IN THE PATIENT, NOTED SUTURE WAS DETACHED FROM ANCHOR. 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 22674056 ↗
• MalfunctionJul 16, 2025Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE WAS FOUND TO BE BROKEN. ACCORDING TO THE REPORTER, WHILE THE SURGEON WAS INSERTING THE FASTIN ANCHOR, STRAIN WAS LOST WHEN PASSING THROUGH THE TISSUE ¿(M.R.)¿, CAUSING THE ANCHOR TO BECOME MISALIGNED OR LOOSENED FROM THE TIP OF THE HANDLE. THE SURGEON ATTEMPTED TO REPOSITION THE ANCHOR BACK IN THE HANDLE, BUT WHEN TRYING TO PASS IT THROUGH THE TISSUE AGAIN, THE TENSION IN THE THREADS WAS LOST. THE SURGEON INDICATED THAT THE ANCHOR DID NOT GRIP PROPERLY, AND WHEN REMOVING THE HANDLE FROM THE ANCHOR, THE ENTIRE SUTURE CAME OUT WITH IT, LEAVING THE ANCHOR IN PLACE WHILE THE THREADS WERE COMPLETELY CUT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523357 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHEN THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR WAS IMPLANTED IN THE PATIENT, THE SUTURE WAS DETACHED FROM ANCHOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148401 ↗
• MalfunctionMay 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN OPENING THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE THE PACKAGING. THEREFORE THE DEVICE WAS NOT REMOVED FROM THE PACKAGING. IT WAS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096462 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR WAS BENT, REMOVED THE ANCHOR FROM PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967170 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT WHEN TIGHTENING THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR A SCREWDRIVER WAS BROKEN, WHICH MADE IT IMPOSSIBLE TO INTRODUCE THE ANCHOR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935751 ↗
• MalfunctionMar 19, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE PULLED OUT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643284 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING FASTIN RC 5.0 W/OCORD W/NDLS DEVICE THE SUTURE FELL APART FROM THE ANCHOR AND THE ANCHOR COULD NOT BE REMOVED. THE DEVICE WAS USED WITH THE 4.75 HEALIX ADVANCE KNTLS PEEK AND THE HEALIX ALL-IN-ONE AWL DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS EVENT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424788 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT ALL THE SUTURES ON THE DEVICE BURST WHEN REMOVING THE STEM AND RELEASING THE SUTURES, LEAVING THE ANCHOR ON THE PATIENT'S PATELLA. THERE WAS PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149393 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURES ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE BROKE WHEN REMOVING THE INSERTER THUS LEAVING THE ANCHOR INSIDE THE PATIENT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19476666 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FASTIN RC 5MM ORTHOCORD W NEEDLES DEVICE WAS BROKEN OFF WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652738 ↗
• MalfunctionJun 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PINHOLE IN THE FOIL WRAPPING OF THE FASTIN RC 5MM ORTHOCORD W NEEDLES DEVICE. ACCORDING TO THE REPORT, THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081159 ↗
• MalfunctionJun 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PINHOLE IN THE FOIL WRAPPING OF THE FASTIN RC 5MM ORTHOCORD W NEEDLES DEVICE. ACCORDING TO THE REPORT, THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081143 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TWO STRANDS ON THE FASTIN RC 5MM ORTHOCORD W NEEDLES DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626059 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE BROKE WHEN TIGHTENING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951512 ↗
• MalfunctionMar 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A TENDON REATTACHMENT PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE INSERTER HANDLE AND DRIVER SHAFT ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE BECAME DISCONNECTED, THUS NOT ALLOWING ANCHOR TO BE ADVANCED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13921299 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN THE (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE THREADS BROKE OFF ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE; AND WAS THEREFORE, COULD NOT BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591677 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT DURING A PETELLA FRACTURE KNEE SURGERY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE WHILE THE SURGEON BEGAN TO MAKE THE KNOTS TO INSERT THE PATELLAR TENDON, THE DEVICE BEGAN TO FRAY AND FINALLY WAS CUT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11081346 ↗
• MalfunctionJul 13, 2020Break; Crack; Break; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE SUTURES ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE WERE FRAYED AND LOOKED DIFFERENT. THEN WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE WHILE BEING USED FOR A FIXATION OF A LIGAMENTUM. THERE WAS A DELAY IN THE SURGERY FOR 20-30 MINUTES DUE TO OPENING A NEW DEVICE, AND REIMPLANTING THE ANCHOR. THE SURGERY WAS COMPLETED WITH SAME LIKE PRODUCT AS ALTERNATIVE PRODUCT WAS READILY AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND NO SURGICAL INTERVENTION PLANNED. IT WAS REPORTED THAT THE USER WAS TRAINED AND THE PRODUCT WAS STORED ACCORDING TO LABELING INSTRUCTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10263909 ↗
• InjuryJan 14, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ACHILLES TENDON REPAIR ON A PATIENT WHOSE DIAGNOSIS WAS RUPTURE OF THE ACHILLES TENDON. THE FASTIN RC 5.0 W/OCORD W/NDLS (1L76564) FAILED WHEN PUTTING THE ANCHOR AND CUTTING THE SUTURE, THE SURGEON HAD TO OPENED ANOTHER FASTIN RC 5.0 W/OCORD W/NDLS (6L28722) THAT WORKED FINE DURING THE SURGERY, BUT AT THE NEXT DAY THE PATIENT AD TO RE-ENTER THE WARD, BECAUSE THE 2ND ANCHOR FAILED AGAIN BUT THIS TIME INSIDE THE PATIENT BODY. THE SURGEON HAD TO USED PRODUCTS FROM THE COMPETITOR. AS PER THE AFFILIATE THE CLINIC ADVISE THEY WILL BE SENDING US A WARNING LETTER AND THEY WILL ALSO INFORM THE CORRESPONDING AUTHORITIES ABOUT THE SITUATION.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 9588490 ↗
• InjuryJan 14, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ACHILLES TENDON REPAIR ON A PATIENT WHOSE DIAGNOSIS WAS RUPTURE OF THE ACHILLES TENDON. THE FASTIN RC 5.0 W/OCORD W/NDLS (1L76564) FAILED WHEN PUTTING THE ANCHOR AND CUTTING THE SUTURE, THE SURGEON HAD TO OPENED ANOTHER FASTIN RC 5.0 W/OCORD W/NDLS (6L28722) THAT WORKED FINE DURING THE SURGERY, BUT AT THE NEXT DAY THE PATIENT AD TO RE-ENTER THE WARD, BECAUSE THE 2ND ANCHOR FAILED AGAIN BUT THIS TIME INSIDE THE PATIENT BODY. THE SURGEON HAD TO USED PRODUCTS FROM THE COMPETITOR. AS PER THE AFFILIATE THE CLINIC ADVISE THEY WILL BE SENDING US A WARNING LETTER AND THEY WILL ALSO INFORM THE CORRESPONDING AUTHORITIES ABOUT THE SITUATION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9588232 ↗
• MalfunctionDec 27, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A QUADRICEPS TENDON TENOGRAPHY AND PATELLAR TENDON INJURY AFTER MAKING A WAY FOR THE ANCHOR SCREW AND AFTER INSERTING THE ANCHOR THE SURGEON PROCEEDED TO REMOVED THE ANCHOR HANDLE AND THE FASTIN RC 5.0 W/OCORD W/NDLS BUT 2 OF THE 4 THAT WERE USED BROKE. FORTUNATELY THE PROCEDURE WAS COMPLETED WITH THE OTHER 2. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527496 ↗
• MalfunctionDec 27, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A QUADRICEPS TENDON TENORPHY AND PATELLAR TENDON INJURY AFTER MAKING A WAY FOR THE ANCHOR SCREW AND AFTER INSERTING THE ANCHOR THE SURGEON PROCEEDED TO REMOVED THE ANCHOR HANDLE AND THE FASTIN RC 5.0 W/OCORD W/NDLS BUT 2 OF THE 4 THAT WERE USED BROKE. FORTUNATELY THE PROCEDURE WAS COMPLETED WITH THE OTHER 2. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527456 ↗

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