Modular Arthrodesis NailRecalls & reported problems across all models
Biomet Orthopedics, LLC · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Modular Arthrodesis Nail model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 6 models of Modular Arthrodesis Nail by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2020 and Jun 12, 2024 — classified as 7 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Modular Arthrodesis Nail 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.
- Nov 29, 2022Open, Classified
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Z-1036-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Modular Arthrodesis Nail problems
Device problems
- Fracture9
- Detachment of Device or Device Component3
- Separation Failure2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
- Migration1
- Off-Label Use1
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient3
- Bone Fracture(s)2
- Ambulation or Postural Difficulties1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
Modular Arthrodesis Nail models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Modular Arthrodesis Nail CP260602ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall1 report
- Modular Arthrodesis Nail CP260600ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- Modular Arthrodesis Nail CP260601ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Modular Arthrodesis Nail CP260605ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Modular Arthrodesis Nail CP260606ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Modular Arthrodesis Nail CP260608ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent Modular Arthrodesis Nail adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19518876 ↗MalfunctionJun 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19518865 ↗MalfunctionMay 1, 2024Fracture; Fracture
IT WAS REPORTED THAT UPON TIGHTENING THE ARTHRODESIS PERIMETER SCREW INTO PLACE DURING FINAL IMPLANTATION, THE SCREW HEAD BROKE OFF. ONCE THE SCREW HEAD BROKE OFF, THE PIECE WAS REMOVED. NO FOREIGN BODIES WERE RETAINED. THE BODY OF THE SCREW WAS LEFT IN PLACE AS THE SURGEON WAS UNABLE TO GET IT OUT TO REPLACE IT WITH A NEW ONE. THE SURFACE OF THE SCREW THAT WAS LEFT IN WAS NOT SITTING ABOVE THE COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221456 ↗MalfunctionNov 29, 2023Fracture; Fracture
IT WAS REPORTED THAT UPON TIGHTENING THE ARTHRODESIS PERIMETER SCREW INTO PLACE DURING FINAL IMPLANTATION, THE SCREW HEAD BROKE OFF. ONCE THE SCREW HEAD BROKE OFF, THE PIECE WAS REMOVED. NO FOREIGN BODIES WERE RETAINED. THE BODY OF THE SCREW WAS LEFT IN PLACE AS THE SURGEON WAS UNABLE TO GET IT OUT TO REPLACE IT WITH A NEW ONE. THE SURFACE OF THE SCREW THAT WAS LEFT IN WAS NOT SITTING ABOVE THE COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226416 ↗InjuryNov 16, 2022Fracture; Unstable; Detachment of Device or Device Component; Migration; Fracture; Unstable; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY AND IT WAS DETERMINED THAT THE LOCKING COLLAR DISASSOCIATED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE IT WAS REVEALED THAT THE SMALL LOCKING SCREWS OF THE COLLAR HAD BACKED OUT AND ONE LOCKING SCREW HAD FRACTURED. THE REVISION SURGERY WAS COMPLETED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 15803961 ↗InjuryAug 8, 2022Fracture; Fracture
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 15186680 ↗InjuryFeb 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT WAS REVISED 3 MONTHS POST REVISION DUE TO LOOSENING. NO ADDITIONAL INFORMATION AVAILABLE. PREVIOUSLY, THE PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE. THE PATIENT SPUN INTO EXTERNAL ROTATION AND WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION. IT WAS ALSO NOTED- HCP USED A DUAL COMPRESS MOD A INTERCALARY SEGMENT AS A MID SHAFT FEMUR INTERCALARY. IT WAS KNOWN TO BE OFF LABEL.
Patient problems: Failure of Implant
MAUDE report 13601094 ↗InjuryFeb 11, 2022Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device
IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT SPUN INTO EXTERNAL ROTATION AND WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION. IT WAS ALSO NOTED- HCP USED A DUAL COMPRESS MOD A INTERCALARY SEGMENT AS A MID SHAFT FEMUR INTERCALARY. IT WAS KNOWN TO BE OFF LABEL. NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 13515208 ↗MalfunctionOct 28, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712076 ↗InjuryAug 31, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 12391350 ↗InjuryAug 31, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE CONNECTOR IS THE DEVICE THAT FRACTURED, NOT THE LOCKING COLLAR. THE INITIAL REPORT SHOULD BE VOIDED.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 12391349 ↗MalfunctionJan 20, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 11202328 ↗MalfunctionJan 13, 2020Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING A REVISION OF A LEFT KNEE OSS SYSTEM DUE TO A BROKEN JUNCTION/CONNECTOR COMPONENT, THE SURGEON STATED THAT THE MORRIS TAPER COULD NOT BE BROKEN FROM THE FEMORAL STEM DESPITE MULTIPLE ATTEMPTS AND DIFFERENT INSTRUMENTS. THE SURGERY HAD TO BE MODIFIED TO CUT THE SEGMENTS APART, EXTENDING SURGICAL TIME BY AN HOUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9580992 ↗MalfunctionJan 13, 2020Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING A REVISION OF A LEFT KNEE OSS SYSTEM DUE TO A BROKEN JUNCTION/CONNECTOR COMPONENT, THE SURGEON STATED THAT THE MORRIS TAPER COULD NOT BE BROKEN FROM THE FEMORAL STEM DESPITE MULTIPLE ATTEMPTS AND DIFFERENT INSTRUMENTS. THE SURGERY HAD TO BE MODIFIED TO CUT THE SEGMENTS APART, EXTENDING SURGICAL TIME BY AN HOUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9580989 ↗
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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