TRIGEN 71649638Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556339749), received between Nov 17, 2020 and Nov 20, 2020 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K092748, K243364); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY INVOLVING A NAIL EXCHANGE WAS PERFORMED DUE TO NON-UNION (MID-SHAFT). THE PATIENT OUTCOME IS UNKNOWN. THE SURGEON DID NOT BLAME THE DEVICE AND HE WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: Failure of Implant

  MAUDE report 10878492 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT META TAN LEFT 10MM X 38 HAD TO BE EXCHANGED DUE TO NON-UNION. NO PATIENT INFORMATION WAS INITIALLY PROVIDED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10850463 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.

• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690