Linvatec SRS PopLok CKP-4502Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854014124), received between Jun 26, 2018 and Oct 7, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJun 26, 2018Material Fragmentation; Activation, Positioning or Separation Problem; Material Fragmentation; Activation, Positioning or Separation Problem

  THE CONMED SALES REPRESENTATIVE REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE CKP-4502 ANCHOR DID NOT DEPLOY PROPERLY AND COULD NOT BE REMOVED FROM THE DRIVER SHAFT. THE SURGEON FORCEFULLY REMOVED THE DRIVER AND ANCHOR FROM THE PATIENT. INSPECTION OF THE ANCHOR SHOWED ONE WING HAD DEPLOYED, AND ONE WING WAS MISSING. THE PROCEDURE WAS COMPLETED AS A SINGLE ROW REPAIR, RATHER THAN A DOUBLE ROW, WITH A 10 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A WING WAS NOT ATTACHED TO THE ANCHOR OR RETURNED FOR EVALUATION; THEREFORE, ITS LOCATION IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF THE UNKNOWN LOCATION OF A NON-BIODEGRADABLE PIECE OF A DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639654 ↗

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.