Linvatec SRS PopLok GKP-2801Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854014117), received between May 29, 2024 and May 19, 2026 — 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.

• 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 ↗
• 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 ↗

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.