VERSALOK ORTHOCORD 210818Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705001323), received between May 21, 2018 and Nov 2, 2023 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

5 other recalls cover devices cleared under the same FDA submission (K100532, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023, ONE EYELET OF THE VERSALOK PEEK ANCHOR WITH ORTHOCORD DEVICE BROKE AS THE SURGEON WAS LOADING THE SECOND PERMACORD SUTURE INTO THE ANCHOR. THE ANCHOR DID NOT COME INTO CONTACT WITH PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18054692 ↗
• MalfunctionOct 11, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576177 ↗
• MalfunctionOct 11, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574812 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT PREOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR ON THE VERSALOK PEEK WITH ORTHOCORD DEVICE WAS BROKEN WITH THE ANCHOR HANDLE WHILE PULLING IT OUT. 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 12474676 ↗
• MalfunctionOct 14, 2020Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE VERSALOK PEEK ANCHOR WITH FREE STRANDS OF #2 ORTHOCORD CRACKED WHEN MALLETING THE BONE. THE SALES REP STATED THAT THE BONE WAS HARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677424 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE UPON INSERTING THE VERSALOK PEEK WITH ORTHOCORD THE ANCHOR BROKE. NO FRAGMENTS WERE LEFT IN THE PATIENT´S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929418 ↗
• InjuryMar 17, 2020Entrapment of Device; Material Separation; Material Twisted/Bent; Entrapment of Device; Material Separation; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT UPON REMOVING THE INSERTER OF THE VERSALOK PEEK ANCHOR WITH FREE STRANDS OF #2 ORTHOCORD FROM THE BONE, THE INSERTER WAS BENT AND THE SUTURES WERE FREED, THE PHYSICIAN WAS ABLE TO RETRIEVE THE INTERNAL PART OF THE DEVICE BUT APPEARS THAT THE OUTER SLEEVE WAS MISSING IN THE PATIENT´S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9842871 ↗
• MalfunctionJun 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE VERSALOK PEEK ANCHOR WITH FREE STRANDS OF ORTHOCORD WAS DEFECTIVE AND COULD NOT BE USED. DETAILED DESCRIPTION WILL FOLLOW. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED WHEN USING AN ANCHOR FROM (B)(6) 2018 THE THREADING OF THE THREADS AND THE SUBSEQUENT WRAPPING WAS EASILY POSSIBLE. HOWEVER, AFTER TIGHTENING WITH THE SPECIAL INSTRUMENTATION, THE ANCHOR COULD NOT BE LOCKED OVER THE HANDLE AS USUAL. IT WAS ALSO REPORTED THAT THE HANDLE COULD BE PRESSED BUT THE THREADS WERE NOT FIXED IN THE STRAINED POSITION. SINCE NO HOLDING FUNCTION WAS POSSIBLE, THE ANCHOR HAD TO BE REMOVED AGAIN AND REPLACED BY ANOTHER ANCHOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731779 ↗
• MalfunctionMay 13, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S VERSALOK PEEK ANCHOR WITH ORTHOCORD DISTAL PORTION OF THE ANCHOR PEELED UP AS IT WAS BEING MALLETED AND WOULD NOT ADVANCE CORRECTLY INTO THE PATIENT. THE SALES REP STATED THAT THE ANCHOR WAS REMOVED WITH NO DEBRIS LEFT BEHIND. THE PATIENT HAD HARD BONE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY. THE ANCHOR IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604600 ↗
• MalfunctionDec 28, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S VERSALOK PEEK ANCHOR WITH ORTHOCORD BROKE AT THE DISTAL END NEAR THE METAL INSERTER WHILE INSERTING INTO THE PATIENT. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE ANCHOR WAS REMOVED FROM THE PATIENT BY PULLING THE SUTURES AND THE INSERTER. THE SALES REP STATED THAT NOTHING WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR TIME DELAY. THE SALES REP STATED THAT THERE WERE NO PROCEDURAL FACTORS THAT CONTRIBUTED TO BREAKAGE, AND THERE IS NO NEED FOR SURGICAL INTERVENTION. THE ANCHOR IS BEING RETURNED FOR EVALUATION. 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 8202355 ↗
• InjuryOct 3, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S VERSALOK PEEK ANCHOR WITH FREE STRANDS OF #2 ORTHOCORD BROKE UPON INSERTION WHILE UNSCREWING THE INSERTER. THE EYELET PORTION OF THE IMPLANT WAS REMOVED FROM THE PATIENT, BUT THE DISTAL PORTION OF THE IMPLANT REMAINED INSIDE THE PATIENT. THE SALES REP STATED THAT THE PATIENT DID NOT HAVE ANY ABNORMAL BONE DENSITY AND THERE WERE NO ABNORMAL PROCEDURAL FACTORS. THE SALES REP STATED THEY ARE NOT PLANNING ANY SURGICAL INTERVENTION. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH A NEW BONE HOLE AND THERE WAS NO DELAY TO THE CASE. THE EYELET PORTION OF THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 7930826 ↗
• InjurySep 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE CUSTOMER'S VERSALOK PEEK ANCHOR WITH FREE STRANDS OF #2 ORTHOCORD DEPLOYED, BUT THE ANCHOR DID NOT STAY IN THE BONE. THE SALES REP STATED THAT IT WAS AN OLDER PATIENT, BUT IN THEIR KNOWLEDGE HAD NORMAL BONE DENSITY. THE CASE WAS COMPLETED WITH A HEALIX ADVANCE KNOTLESS ANCHOR WITH NO PATIENT HARM. THERE WAS A FIVE TO TEN MINUTE DELAY TO GET THE SUTURE OUT OF THE ANCHOR AND GRAB THE DIFFERENT DEVICE TO COMPLETE THE CASE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. ADDITIONAL INFORMATION FROM SALES REP 8/24/18: NO THE SAME BONE HOLE WAS NOT USED THEY CREATED A NEW BONE HOLE. THE IMPLANT WAS REMOVED AND THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE TYPE OF FORCE USED WHEN THE ANCHOR PULLED OUT WAS NORMAL FORCE. NO THE ANCHOR DIDN'T REMAIN ON THE INSERTER AFTER REMOVAL IT CAME OUT OF THE CANNULA. THE SURGEON PULLED WHILE TURNING. NO INFORMATION IS AVAILABLE IF THE SUTURE WRAP AROUND THE HANDLE OR DRIVER. THE SURGEON DID GRASP THE SUTURE DURING INSERTION AND REMOVAL. DID THE SURGEON USE APPROPRIATE DOWNWARD FORCE APPLIED WITH DRIVING ANCHOR IN? HE HAMMERED THE ANCHOR IN. WHICH SUTURE LIMBS WERE TESTED TO VERIF

  Patient problems: Tissue Damage

  MAUDE report 7865057 ↗
• MalfunctionSep 4, 2018Positioning Failure; Positioning Failure

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S VERSALOK PEEK W/ORTHCORD DID NOT DEPLOY THE IMPLANT DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO NEW BONE HOLES WERE CREATED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2017: WHEN WAS THE ISSUE DETECTED? DURING THE CASE. WAS THERE A RESULTING SURGICAL DELAY - HOW LONG? NO. WAS THE PROCEDURE ABLE TO BE COMPLETED? YES. WERE ALTERNATIVES READILY AVAILABLE? YES. ANY PATIENT IMPACT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841540 ↗
• MalfunctionSep 3, 2018Positioning Failure; Positioning Failure

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S VERSALOK PEEK W/ORTHCORD DID NOT DEPLOY THE IMPLANT DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO NEW BONE HOLES WERE CREATED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08-16-17. WHEN WAS THE ISSUE DETECTED? DURING THE CASE. WAS THERE A RESULTING SURGICAL DELAY - HOW LONG? NO. WAS THE PROCEDURE ABLE TO BE COMPLETED? YES. WERE ALTERNATIVES READILY AVAILABLE? YES. ANY PATIENT IMPACT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840657 ↗
• MalfunctionAug 18, 2018Positioning Failure; Positioning Failure

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S VERSALOK PEEK W/ORTHCORD DID NOT DEPLOY THE IMPLANT DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO NEW BONE HOLES WERE CREATED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08-16-2017: WHEN WAS THE ISSUE DETECTED? DURING THE CASE. WAS THERE A RESULTING SURGICAL DELAY - HOW LONG? NO. WAS THE PROCEDURE ABLE TO BE COMPLETED? YES. WERE ALTERNATIVES READILY AVAILABLE? YES. ANY PATIENT IMPACT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796090 ↗
• MalfunctionAug 16, 2018Break; Break

  OUR AFFILIATE REPORTED ON INSERTION, THE VERSALOK ANCHORS BROKE DISTALLY. ALL 3 ANCHORS WERE FROM THE SAME LOT NUMBER. REPLACED WITH THE SAME DEVICE FROM A DIFFERENT LOT NUMBER AND CASE PROCEEDED. NO FURTHER INFORMATION ARE AVAILABLE AT THIS STAGE. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-53554 AND 1221934-2018-53555.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790589 ↗
• MalfunctionAug 16, 2018Break; Break

  OUR AFFILIATE REPORTED ON INSERTION, THE VERSALOK ANCHORS BROKE DISTALLY. ALL 3 ANCHORS WERE FROM THE SAME LOT NUMBER. REPLACED WITH THE SAME DEVICE FROM A DIFFERENT LOT NUMBER AND CASE PROCEEDED. NO FURTHER INFORMATION ARE AVAILABLE AT THIS STAGE. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-53554 AND 1221934-2018-53556.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790555 ↗
• MalfunctionAug 16, 2018Break; Break

  OUR AFFILIATE REPORTED ON INSERTION, THE VERSALOK ANCHORS BROKE DISTALLY. ALL 3 ANCHORS WERE FROM THE SAME LOT NUMBER. REPLACED WITH THE SAME DEVICE FROM A DIFFERENT LOT NUMBER AND CASE PROCEEDED. NO FURTHER INFORMATION ARE AVAILABLE AT THIS STAGE. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-53555 AND 1221934-2018-53556.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790519 ↗
• MalfunctionAug 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE SALES REPRESENTATIVE STATED THAT THE CUSTOMER'S VERSALOK PEEK WITH ORTHOCORD STAYED ON THE INSERTER WHEN DEPLOYED. THE SUTURES WERE NOT LOCKED IN THE ANCHOR. THE SALES REPRESENTATIVE STATED THAT THE PATIENT HAD SOFT BONE. THE CASE WAS COMPLETED BY USING ANOTHER ANCHOR IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED FOR EVALUATION. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781806 ↗
• MalfunctionAug 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE CALL THAT THEIR VERSALOK PEEK WITH ORTHOCORD FAILED AT A ROTATOR CUFF REPAIR FOR THEIR CUSTOMER. THE WIRE BROKE ON THE SUTURE PRIOR TO USING IT ON THE PATIENT ONCE REMOVED FROM PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE NOR TIME DELAYS REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775618 ↗
• MalfunctionJul 18, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE NOSE OF HIS VERSALOCK PEEK ANCHOR WITH FREE STRANDS OF #2 ORTHOCORD BROKE UPON INSERTION. THE SALES REPRESENTATIVE STATED THAT THE SURGEON FULLY REMOVED THE BROKEN PIECES AND DRILLED A PILOT HOLE WHEN INSERTING THE 2ND ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE STATED THE BONE QUALITY WAS VERY HARD. THE PATIENT WAS AN OLDER MALE BUT HE DID NOT GIVE AN AGE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700054 ↗
• MalfunctionJul 18, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE VERSALOK PEEK ANCHOR BROKE OFF AS THE SURGEON WAS THREADING THE SUTURES THROUGH PRIOR TO BEING INSERTED INTO THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7699557 ↗
• MalfunctionJun 27, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE VERSALOK PEEK ANCHOR DEVICE BROKE UPON INSERTION. ACCORDING TO THE REPORT, THE DEVICE WAS REMOVED AND ANOTHER ANCHOR WAS INSERTED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. IT WAS FURTHER REPORTED THAT ALL BROKEN PIECES WERE REMOVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641781 ↗
• MalfunctionJun 26, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THE EYELET ON TWO OF THEIR VERSALOK PEEK ANCHOR'S BROKE WHILE PULLING SUTURES THROUGH THE ANCHOR BEFORE INSERTION DURING A ROTATOR CUFF PROCEDURE. HE STATED IT HAPPENED TWO TIMES IN A ROW AND THE THIRD ANCHOR THEY WENT TO PULL SUTURES THROUGH WORKED FINE. ALL OF THIS HAPPENED OUTSIDE OF THE BODY WHILE PREPPING THE ANCHORS. THERE WERE NO PATIENT CONSEQUENCES AND A FIVE (5) MINUTE DELAY. THE BROKEN DEVICES WERE ALREADY DISCARDED BY THE CUSTOMER. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52218.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638528 ↗
• MalfunctionJun 26, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THE EYELET ON TWO OF THEIR VERSALOK PEEK ANCHOR'S BROKE WHILE PULLING SUTURES THROUGH THE ANCHOR BEFORE INSERTION DURING A ROTATOR CUFF PROCEDURE. HE STATED IT HAPPENED TWO TIMES IN A ROW AND THE THIRD ANCHOR THEY WENT TO PULL SUTURES THROUGH WORKED FINE. ALL OF THIS HAPPENED OUTSIDE OF THE BODY WHILE PREPPING THE ANCHORS. THERE WERE NO PATIENT CONSEQUENCES AND A FIVE (5) MINUTE DELAY. THE BROKEN DEVICES WERE ALREADY DISCARDED BY THE CUSTOMER. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50857.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638492 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100532, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy 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, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726