Linvatec SRS PopLok CKP-4500Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20845854014100), received between Jul 2, 2018 and Dec 5, 2024 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K091549); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  THE DISTRIBUTOR REPORTED THAT CKP-4500, POPLOK SUTURE ANCHOR, 4.5 MM, WAS BEING USED ON (B)(6)2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿IT HITS WIDE, AND THE TIP IS DISASSEMBLED, AND THE SCREW IS BROKEN.¿. FURTHER ASSESSMENT QUESTIONS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE POSSIBILITY OF THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20852475 ↗
• MalfunctionNov 3, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, CKP-4500, 4.5MM POPLOK SUTURE ANCHOR, WAS BEING USED DURING AN ACL & PCL WITH MENISCUS REPAIR PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿NOT WORK DURING THE SURGERY TIMING.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PICTURES RECEIVED SHOW THE DEVICE HAS BEEN BROKEN; HOWEVER, IT IS NOT KNOWN WHEN THE BREAKAGE OCCURRED OR IF IN CONTACT WITH THE PATIENT. A GOOD FAITH EFFORT WAS MADE TO GAIN INFORMATION FROM THE REPORTER, BUT WE HAVE NOT RECEIVED AN ANSWER TO DATE. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066961 ↗
• MalfunctionJun 28, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CKP-4500, 4.5MM POPLOK SUTURE ANCHOR WAS BEING USED (B)(6) 2023 DURING A TIBIAL SPINE RECONSTRUCTION AND ¿THE ESTRUCTURE OF THE IMPLANT IS BROKEN¿. THERE WAS NO INJURY TO THE PATIENT OR THE USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR KNOWN HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE. ALL FRAGMENTS WERE RECOVERED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219309 ↗
• InjuryApr 17, 2023Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT THE CKP-4500 4.5MM POPLOK SUTURE ANCHOR WAS BEING USED ON (B)(6) 2023 DURING A SHOULDER ARTHROSCOPY PROCEDURE AND ¿CCF STATES: AFTER 4.5MM AWL BEING MALLET UNTIL LASER LINE, POPLOK 4.5 IS LOADED WITH 3 LIMBS OF MITEK- HEALIX ADVANCE BR ANCHOR W. PERMACORD AND MALLET IN UNTIL LASER LINE. THEN DR TENSION LIMBS BY PULLING ONE BY ONE. AFTER HE HAD TIGHTENED ALL LIMBS, THEN HE PRESSES TO DEPLOY AND ¿POP¿ SOUND IS HEARD. WHEN HE WANTED TO TAKE OUT POPLOK 4.5 HANDLE, HE FOUND THAT IT IS STUCK AND ADVICE BEEN GIVEN TO HIM BY TURN THE RED KNOB ANTICLOCKWISE TO RELEASE IT BUT HE STILL CAN¿T TAKE HANDLE OUT EVEN THIS ACTION BEEN DONE. WITH NO CHOICE HE HAD TO BACKSLAPS THE HANDLE AND FOUND THAT ANCHOR WINGS IS OPEN BOTH SIDE BUT IT STILL SIT ON HANDLE. HE DESTROYED THE ANCHOR AND TAKE IT OUT. DUE TO BACKSLAP, PATIENT BONE HAVING SOME DAMAGE ON THAT AREA AND REPAIR DONE BY BONE WAX. SURGEON HAD TO CUT AND OPEN AN INCISION AT LOWER PART OF GT (ALMOST NEAR TO NECK) TO DEPLOYED ANOTHER 4.5MM POPLOK IN WITH THE SAME 3 LIMBS.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND THERE WAS A 30 MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 16753329 ↗
• MalfunctionJan 17, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CKP-4500, 4.5MM POPLOK SUTURE ANCHOR, WAS BEING USED DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿THE ANCHOR IS RETURNED AFTER ITS INSERTION INTO THE BONE.¿ IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED USING AN ALTERNATE 4.5 MM POPLOCK SUTURE ANCHOR WITH A 5-MINUTE DELAY IN THE PROCEDURE. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED ¿WITH THE HELP OF TWEEZERS AND OPEN SURGERY FORCEPS¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿RECOVERED¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183371 ↗
• InjuryJul 18, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CKP-4500, 4.5MM POPLOK SUTURE ANCHOR WAS BEING USED ON (B)(6) 2022 DURING A CRUCIATE LIGAMENT RECONSTRUCTION AND "WHEN INSERTING THE IMPLANT INTO THE HOLE, IT FRAGMENTS.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE. A GOOD FAITH EFFORT WAS ATTEMPTED TO GAIN FURTHER INFORMATION; HOWEVER, TO DATE NO REPLY HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE LACK OF INFORMATION REGARDING RECOVERY OF FRAGMENTS FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15043560 ↗
• MalfunctionFeb 9, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CKP-4500, 4.5MM POPLOK SUTURE ANCHOR WAS BEING USED ON (B)(6) 2022 DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE AND ¿WHEN INSERTING THE IMPLANT INTO THE HOLE, IT FRAGMENTS.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE. FURTHER ASSESSMENT FOUND, ¿NO FRAGMENTS REMAINED AT THE SURGICAL SITE¿. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496858 ↗
• InjuryAug 16, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT CKP-4500 DEVICE WAS USING DURING A ROTATOR CUFF REPAIR ON (B)(6) 2019. ONE ANCHOR WAS IMPLANTED AND FOUND TO BE BROKEN IN PLACE UPON REMOVAL OF THE INSERTER. THE SECOND ANCHOR WAS FOUND TO BE BROKEN IN THE INSERTER. THE IMPLANTED ANCHOR HAD FRAGMENTED AND THE SURGEON CHOSE TO LEAVE THE FRAGMENT IN THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS IN THE HOLE OR LOOSE UPON REVIEW, THE REPORTER DID NOT ADVISE TO THIS EXTENT. THERE WAS NO INJURY TO THE PATIENT OR USER REPORTED. THERE WAS ALSO NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THIS EVENT. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENT'S UNKNOWN LOCATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8900639 ↗
• MalfunctionJun 19, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED AN ISSUE WITH THE 4.5MM POPLOK SUTURE ANCHOR, ITEM # CKP-4500, LOT # 976953 THAT OCCURRED ON (B)(6) 2019 DURING A ROTATOR CUFF REPAIR INVOLVING A MALE PATIENT. IT WAS REPORTED THAT APPROXIMATELY 60 MINUTES INTO THE PROCEDURE (3/4 OF THE WHOLE PROCEDURE) THE POPLOK BROKE INTO TWO PIECES UPON BEING DEPLOYED. THE ANCHOR WAS REMOVED FROM THE SHOULDER AND REMOVED FROM THE SUTURES IT WAS ATTACHED TO. ALL PIECES WERE RETRIEVED. IT IS NOTED THAT THIS WAS THE FIRST POPLOK BEING USED IN THE PROCEDURE. TWO MORE POPLOKS WERE USED AFTER AND WORKED AS NORMAL. IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER POPLOK WITH A REPORTED 2- MINUTE DELAY. IT IS INDICATED THAT THE DEVICE WAS DISCARDED POST-OP BY THE FACILITY. THIS REPORT IS BEING RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711571 ↗
• InjuryMar 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CKP-4500, 4.5MM POPLOK SUTURE ANCHOR, DEVICE WAS BEING USED DURING A PROCEDURE ON (B)(6) 2019 AND THE DEVICE IS REPORTED AS HAVING "SPLIT IN TO TWO PIECES AS IT WAS BEING INSERTED". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED FOR ASSESSMENT; HOWEVER, NO FURTHER RESPONSE HAS BEEN RECEIVED FROM THE REPORTER. PREVIOUSLY THIS DEVICE HAS HAD A FILING WITHIN TWO-YEARS FOR INJURY BASED ON BREAKAGE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO A REPORT OF BREAKAGE DURING USE AND NO FURTHER INFORMATION BEING AVAILABLE FOR ASSESSMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439332 ↗
• MalfunctionFeb 21, 2019Material Separation; Failure to Eject; Material Separation; Failure to Eject

  THE CUSTOMER REPORTED AN ISSUE WITH THE 4.5MM POPLOK SUTURE ANCHOR, ITEM # CKP-4500, LOT # 971177 THAT OCCURRED ON (B)(6) 2019 DURING A ROTATOR CUFF REPAIR INVOLVING A FEMALE PATIENT. IT WAS REPORTED THAT AFTER MAKING A PILOT HOLE USING PKL-45M, THE SURGEON LOADED 4 SUTURES INTO THE LOOP AND PLACED THE TIP OF ANCHOR UNTIL THE REQUIRED DEPTH MARK WAS REACHED. AFTER PUSHING THE TRIGGER, THE ANCHOR WAS NOT DETACHED FROM A DRIVER AND IT WAS PULLED OUT WITH THE DRIVER. IT WAS DETERMINED THAT ONE OF WINGS HAD BROKEN OFF INSIDE THE PATIENTS BODY. THE BROKEN PIECE WAS REMOVED USING A GRASPER AND IT WAS DISPOSED OF AT THE HOSPITAL. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER CKP-4500 WITH A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357688 ↗
• MalfunctionNov 27, 2018Break; Break

  THE CUSTOMER REPORTED AN ISSUE WITH THE 4.5MM POPLOK SUTURE ANCHOR, ITEM CKP-4500, LOT # 948639 THAT OCCURRED DURING A ROTATOR CUFF REPAIR SURGERY INVOLVING A (B)(6) YR OLD MALE ON (B)(6) 2018. IT WAS REPORTED THAT AFTER MAKING A PILOT HOLE USING PKL-45M, THE SURGEON PASSED SUTURES THROUGH THE POPLOK ANCHOR USING SUTURE LOADING TAB AND ADVANCED THE ANCHOR HEAD INTO THE PILOT HOLE USING A MALLET. AFTER THAT, THE SURGEON NOTICED THAT THE ANCHOR WAS BROKEN INSIDE OF THE PATIENT'S BODY DUE TO THE HARD BONE. THE BROKEN PIECE WAS REMOVED USING A GRASPER. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5-MINUTE DELAY USING AN ALTERNATIVE FOOT PRINT DEVICE. THIS REPORT IS RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105687 ↗
• MalfunctionJul 2, 2018Break; Break

  THIS DISTRIBUTOR REPORTED THAT THE CKP-4500, 4.5MM POPLOK SUTURE ANCHOR, ANCHOR BROKE INTO 3 PIECES AFTER INSERTION INTO THE BONE DURING A ROTATOR CUFF REPAIR ON (B)(6) 2018 CAUSING A 2-MINUTE DELAY IN THE PROCEDURE. ALL PIECES WERE REMOVED USING A GRASPER. NO MEDICAL INTERVENTION OR EXTENDED HOSPITAL STAY WAS REQUIRED FOR THE PATIENT; AS THE PATIENT WAS REPORTED HAVING NO INJURIES. THE REPORTER STATES THAT THE PATIENT WAS NOT "AFFECTED" BY THE EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7654798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091549. One submission often covers many models, so check the product and lot details in each record.

• Z-0253-2018 · Apr 17, 2017 · Terminated
  Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.