Gentle Threads 905612Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304008526), received between Jul 11, 2018 and Jul 11, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K982497); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 20, 2018Terminated

   The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

   Z-3176-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679937 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679931 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679924 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679721 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679686 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679677 ↗
• MalfunctionJul 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS NOT THE CORRECT PRODUCT AND DID NOT MATCH THE PRODUCT ID ON THE OUTER LABEL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679503 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982497. One submission often covers many models, so check the product and lot details in each record.

• Z-3177-2018 · Jul 20, 2018 · Terminated
  Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
• Z-1739-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1734-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1945-2015 · Jun 3, 2015 · Terminated
  Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures