Gentle ThreadsRecalls & reported problems across all models
Biomet Orthopedics, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 2
We found 8 models of Gentle Threads by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Sep 3, 2024 — classified as 5 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 reports).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Gentle Threads recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 20, 2018Terminated
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Z-3177-2018 · Root cause: Process control · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Gentle Threads problems
Device problems
- Device Markings/Labelling Problem7
- Fracture6
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Known Impact Or Consequence To Patient8
- No Clinical Signs, Symptoms or Conditions3
- Adhesion(s)2
- Foreign Body In Patient2
- Loss of Range of Motion2
- Scar Tissue2
- Failure of Implant1
Gentle Threads models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gentle Threads 905612Screw, fixation, bone1 recall7 reports
- Gentle Threads 905629FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall0 reports
- Gentle Threads 905608FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- Gentle Threads 905604Screw, fixation, bone2 reports
- Gentle Threads 905617FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- Gentle Threads 905616Screw, fixation, bone1 report
- Gentle Threads 905605FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- Gentle Threads 905627Screw, fixation, bone1 report
Recent Gentle Threads adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20130505 ↗MalfunctionJun 6, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SCREW FRACTURED DURING THE RECONSTRUCTION OF A RIGHT POSTERIOR LIGAMENT AND REINSERTION OF THE POSTERIOR HORN OF THE MENISCUS ARTHROSCOPICALLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17070366 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD STIFFNESS AND LIMITED RANGE OF MOTION THREE WEEKS POST-SURGERY. THE PATIENT UNDERWENT MOBILIZATION UNDER GENERAL ANESTHESIA. SIX MONTHS POST-SURGERY, THE PATIENT HAD FULL RECOVERY OF ROM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Loss of Range of Motion
MAUDE report 16195617 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD STIFFNESS AND LIMITED RANGE OF MOTION THREE WEEKS POST-SURGERY. THE PATIENT UNDERWENT MOBILIZATION UNDER GENERAL ANESTHESIA. SIX MONTHS POST-SURGERY, THE PATIENT HAD FULL RECOVERY OF ROM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Loss of Range of Motion
MAUDE report 16195604 ↗InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR FIBROSIS RESECTION THREE MONTHS POST IMPLANTATION DUE TO CYCLOPS SYNDROME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Adhesion(s); Scar Tissue
MAUDE report 16138619 ↗InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR FIBROSIS RESECTION THREE MONTHS POST IMPLANTATION DUE TO CYCLOPS SYNDROME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Adhesion(s); Scar Tissue
MAUDE report 16138334 ↗InjurySep 1, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 12410609 ↗MalfunctionJul 1, 2021Fracture; Fracture
IT WAS REPORTED THE SCREW BROKE WHILE DURING THE SURGERY. ANOTHER GT SCREW WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100838 ↗MalfunctionJun 25, 2021Fracture; Fracture
IT WAS REPORTED THAT THE INTERFERENCE SCREW WAS BROKEN WHILE FIXING. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12068819 ↗MalfunctionSep 3, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10489267 ↗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 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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