Linvatec SRS PopLok CKP-3501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854013714), received between May 25, 2021 and May 25, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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.