Linvatec SRS PopLokRecalls & reported problems across all models
Conmed Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 5 models of Linvatec SRS PopLok by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and May 19, 2026 — classified as 6 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (18 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Linvatec SRS PopLok problems
Device problems
- Material Fragmentation18
- Break2
- Failure to Eject2
- Activation, Positioning or Separation Problem1
- Expiration Date Error1
- Material Deformation1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Unspecified Musculoskeletal problem1
Linvatec SRS PopLok models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Linvatec SRS PopLok CKP-4500FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE13 reports
- Linvatec SRS PopLok CKP-4502FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE4 reports
- Linvatec SRS PopLok CKP-3500FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- Linvatec SRS PopLok GKP-2801FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- Linvatec SRS PopLok CKP-3501FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
Recent Linvatec SRS PopLok adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Material Fragmentation
THE CUSTOMER REPORTED THAT THE DEVICE, GKP-2801, SUTURE ANCHOR WITH ONE #2 (5 METRIC) HI-FI SUTURE,2.8 MM, WAS USED DURING A RC REPAIR PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DURING A SURGICAL PROCEDURE ONE POPLOK SUTURE 2.8MM ANCHOR WAS FOUND DAMAGED.¿. THE DRIVER TIP FRAGMENTATION HAD FALLEN IN THE PATIENT; HOWEVER, THE FRAGMENTATION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH AN ALTERNATE, UNKNOWN DEVICE. BOTH THE PATIENT AND DOCTOR WERE REPORTED AS ¿GOOD¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. 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 25215064 ↗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 ↗MalfunctionMay 29, 2024Material Fragmentation; Material Fragmentation
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE GKP-2801, 2.8 MM POPLOK SUTURE ANCHOR, DEVICE WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿SURGEON FOLLOWED THE IFU TO USE POPLOK 2.8MM. HE DRILLED PILOT HOLE AND INSERTED ANCHOR. WHILE TENSIONING SUTURE, THE SUTURE SLIPPED OUT FROM THE ANCHOR AND THE IMPLANT BROKE AT DISTAL END.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿RECOVERING WELL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 19416483 ↗MalfunctionMay 29, 2024Material Fragmentation; Material Fragmentation
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE GKP-2801, 2.8 MM POPLOK SUTURE ANCHOR, DEVICE WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) WHEN IT WAS REPORTED ¿SURGEON FOLLOWED THE IFU TO USE POPLOK 2.8MM. HE DRILLED PILOT HOLE AND INSERTED ANCHOR. WHILE TENSIONING SUTURE, THE SUTURE SLIPPED OUT FROM THE ANCHOR AND THE IMPLANT BROKE AT DISTAL END.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿RECOVERING WELL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 19416480 ↗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 ↗MalfunctionOct 7, 2022Material Fragmentation; Material Fragmentation
THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE CKP-4502, 4.5MM POPLOK SUTURE ANCHOR, WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿THE ANCHORS WERE BROKEN DURING THE SURGERY.¿ FURTHER ASSESSMENT QUESTIONING FOUND ¿WHEN THE SAFETY LOCK WAS DEACTIVATED AND THE LEVER WAS SQUEEZED, THE WINGS WERE BROKEN.¿ THE DEVICE DID FRAGMENT AND WAS RETRIEVED USING AN ¿INSTRUMENT FROM THE HOSPITAL¿. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR AND THERE WAS NO DELAY REPORTED DURING THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS ¿GOOD, NO COMPLICATIONS¿. 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 15562983 ↗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 ↗InjuryMay 25, 2021Expiration Date Error; Expiration Date Error
THE SALES MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT THE CKP-3501 DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2021 WHEN IT WAS REPORTED THAT "I HAD A REP IMPLANT AN EXPIRED ANCHOR YESTERDAY. THE EXPIRATION SAID "2021-04-17"." THERE WAS NO REPORT OF PATIENT IMPACT. A GOOD FAITH ATTEMPT WAS MADE TO OBTAIN FURTHER INFORMATION, BUT TO DATE NO RESPONSE HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO IMPLANTING AN EXPIRED DEVICE IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11875842 ↗MalfunctionSep 24, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT CKP-4502 DEVICE WAS BEING USED DURING A SHOULDER SURGERY ON (B)(6) 2019 WHEN THE DEVICE BROKE DURING THE POSITIONING PHASE. THE FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT AND ADDITIONAL CKP-4502 DEVICES WERE USED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF USER OR PATIENT INJURY. THERE WAS NOT REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THIS 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 9108765 ↗MalfunctionSep 24, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT CKP-4502 DEVICE WAS BEING USED DURING A SHOULDER SURGERY ON (B)(6) 2019 WHEN THE DEVICE BROKE DURING THE POSITIONING PHASE. THE FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT AND ADDITIONAL CKP-4502 DEVICES WERE USED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF USER OR PATIENT INJURY. THERE WAS NOT REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THIS 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 9108764 ↗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 ↗
Other Conmed Corporation products
All Conmed Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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