Linvatec SRS PopLok CKP-3500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854013851), received between Jun 21, 2019 and Jul 22, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED AN ISSUE WITH THE 3.5MM POPLOK SUTURE ANCHOR, ITEM # CKP-3500, LOT # 1007353 THAT OCCURRED ON (B)(6) 2019 DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR INVOLVING A (B)(6)-YEAR OLD FEMALE. IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, AFTER MAKING PILOT HOLE USING 3.5MM POPLOK PUNCH AND PLACING THE ANCHOR UNTIL THE DISTAL DEPTH MARK, THE SURGEON PASSED SUTURES THROUGH THE POPLOK ANCHOR USING SUTURE LOADING TAB AND INSERTED THE ANCHOR HEAD INTO THE PILOT HOLE. WHEN PUSHING A TRIGGER, THE ANCHOR WAS NOT DETACHED FROM A DRIVER. THE SURGEON USED EXCESSIVE FORCE TO DETACH THE ANCHOR, AND THEN THE WINGS WERE BROKEN. THE BROKEN PIECES WERE COMPLETELY REMOVED USING A GRASPER, AND THEY WERE DISPOSED OF AT THE HOSPITAL. IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CKP-3500 POPLOK WITH A REPORTED 10- MINUTE DELAY. 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 8811855 ↗
• MalfunctionJul 22, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED AN ISSUE WITH THE 3.5MM POPLOK SUTURE ANCHOR, ITEM # CKP-3500, LOT # 1007901 THAT OCCURRED ON (B)(6) 2019 DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR INVOLVING A (B)(6) YEAR OLD MALE. IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, AFTER MAKING PILOT HOLE USING 3.5MM POPLOK PUNCH AND PLACING THE ANCHOR UNTIL THE DISTAL DEPTH MARK, THE SURGEON PASSED SUTURES THROUGH THE POPLOK ANCHOR USING SUTURE LOADING TAB AND INSERTED THE ANCHOR HEAD INTO THE PILOT HOLE. WHEN PUSHING A TRIGGER, THE ANCHOR WAS NOT DETACHED FROM A DRIVER. THE SURGEON USED EXCESSIVE FORCE TO DETACH THE ANCHOR, AND THEN THE WINGS WERE BROKEN. THE BROKEN PIECES WERE COMPLETELY REMOVED USING A GRASPER, AND THEY WERE DISPOSED OF AT THE HOSPITAL. IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CKP-3500 POPLOK WITH A REPORTED 15- MINUTE DELAY. 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 8811835 ↗
• MalfunctionJun 21, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED AN ISSUE WITH THE 3.5MM POPLOK SUTURE ANCHOR, ITEM # CKP-3500, LOT # 988733 THAT OCCURRED ON (B)(6) 2019 DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR INVOLVING A (B)(6) YEAR OLD MALE. IT WAS REPORTED AFTER MAKING PILOT HOLE USING 3.5MM POPLOK PUNCH AND PLACING UNTIL THE DISTAL DEPTH MARK, THE SURGEON PASSED SUTURES THROUGH THE POPLOK ANCHOR USING SUTURE LOADING TAB AND INSERTED THE ANCHOR HEAD INTO THE PILOT HOLE. WHEN TENSIONING SUTURES, THE WINGS WERE BROKEN AND THE SURGEON REMOVED THEM FROM A PATIENT'S BODY. A COMPLAINT PRODUCT IS AVAILABLE FOR RETURN WITHOUT THE BROKEN PIECES AS THE BROKEN PIECES WERE DISPOSED OF AT A HOSPITAL. 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 5- MINUTE DELAY. 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 8721906 ↗

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.