PreciceRecalls & reported problems across all models
Nuvasive Specialized Orthopedics, Inc. · 38 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Precice model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 38 models of Precice by Nuvasive Specialized Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2021 and Mar 11, 2026 — classified as 4 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Precice 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.
- Oct 29, 2021Open, Classified
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
Z-0319-2022 · Root cause: Device Design · names 30 of these models · Recall details · FDA record ↗
Most reported Precice problems
Device problems
- Break4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Corroded1
- Defective Device1
- Fracture1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Deformity/ Disfigurement1
- Insufficient Information1
Precice models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precice LSC5-750-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-700-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-650-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-600-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-550-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-500-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-450-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-400-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-350-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-300-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-250-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC5-200-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-600-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-550-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-500-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-450-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-400-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-350-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-300-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-250-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSC4-200-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-600-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-550-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-500-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-450-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-400-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-350-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-300-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-250-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice LSB3-200-SRod, Fixation, Intramedullary And Accessories1 recall0 reports
- Precice CTL4.5-040-SRod, Fixation, Intramedullary And Accessories2 reports
- PRECICE AST11.5-40300ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Precice CTL4.5-055-SRod, Fixation, Intramedullary And Accessories1 report
- Precice CTL4.5-050-SRod, Fixation, Intramedullary And Accessories1 report
- Precice CTL4.5-044-SRod, Fixation, Intramedullary And Accessories1 report
- Precice CTL4.5-028-SRod, Fixation, Intramedullary And Accessories1 report
- Precice CTL4.5-024-SRod, Fixation, Intramedullary And Accessories1 report
- Precice CTL4.5-022-SRod, Fixation, Intramedullary And Accessories1 report
Recent Precice adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Fracture
THE SURGEON COMPLETED A REVISION ANKLE FUSION. THE ANKLE SALVAGE NAIL WAS BROKEN AND NEEDED TO BE REMOVED AND REVISED WITH A NEW HIND FOOT NAIL. PRECICE ANKLE SALVAGE NAIL WAS REMOVED SUCCESSFULLY.
Patient problems: Failure of Implant
MAUDE report 24575753 ↗MalfunctionNov 30, 2021Break; Corroded; Break; Corroded
INFORMATION WAS RECEIVED THAT DURING EXPLANT A BROKEN SCREW WAS DISCOVERED IN THE RIGHT TIBIAL CONSTRUCT. THE BROKEN PORTION OF THE SCREW REMAINS IMPLANTED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DEBRIS/CORROSION. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 12899615 ↗MalfunctionOct 13, 2021Break; Break
INFORMATION WAS RECEIVED THAT A BROKEN SCREW WAS EXTRACTED. NO PATIENT ADVERSE EVENT WAS REPORTED. REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 12628480 ↗MalfunctionMay 26, 2021Break; Break
INFORMATION WAS RECEIVED THAT DURING REMOVAL, THE LOCKING SCREW BROKE. IT IS BELIEVED THAT THE SCREW BROKE DUE TO EXCESSIVE TORQUE APPLIED FROM THE POWER DRILL.
Patient problems: Insufficient Information
MAUDE report 11887051 ↗InjuryApr 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 TO ADDRESS LOOSE SCREWS. AS PER THE REPORTER, APPROXIMATELY TWO AND A HALF WEEKS POST-IMPLANTATION, IT WAS DISCOVERED THAT THE SCREWS IN THE PROXIMAL BONE SEGMENT HAD LOOSENED AND DISENGAGED THE PLATE. NO PATIENT ADVERSE EVENT WAS REPORTED. DURING THE REVISION, THE SCREWS WERE RE-TIGHTENED AND THE SCREW HOLES WERE BACK-FILLED WITH CEMENT TO PREVENT FUTURE SCREW BACK-OUT. POST REVISION, THE PATIENT HAS SUCCESSFULLY RESUMED LENGTHENING. REPORT 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712092 ↗InjuryApr 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 TO ADDRESS LOOSE SCREWS. AS PER THE REPORTER, APPROXIMATELY TWO AND A HALF WEEKS POST-IMPLANTATION, IT WAS DISCOVERED THAT THE SCREWS IN THE PROXIMAL BONE SEGMENT HAD LOOSENED AND DISENGAGED THE PLATE. NO PATIENT ADVERSE EVENT WAS REPORTED. DURING THE REVISION, THE SCREWS WERE RE-TIGHTENED AND THE SCREW HOLES WERE BACK-FILLED WITH CEMENT TO PREVENT FUTURE SCREW BACK-OUT. POST REVISION, THE PATIENT HAS SUCCESSFULLY RESUMED LENGTHENING. REPORT 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712089 ↗InjuryApr 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 TO ADDRESS LOOSE SCREWS. AS PER THE REPORTER, APPROXIMATELY TWO AND A HALF WEEKS POST-IMPLANTATION, IT WAS DISCOVERED THAT THE SCREWS IN THE PROXIMAL BONE SEGMENT HAD LOOSENED AND DISENGAGED THE PLATE. NO PATIENT ADVERSE EVENT WAS REPORTED. DURING THE REVISION, THE SCREWS WERE RE-TIGHTENED AND THE SCREW HOLES WERE BACK-FILLED WITH CEMENT TO PREVENT FUTURE SCREW BACK-OUT. POST REVISION, THE PATIENT HAS SUCCESSFULLY RESUMED LENGTHENING. REPORT 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712088 ↗InjuryMar 30, 2021Break; Break
IT WAS REPORTED THAT IN THE EARLY LENGTHENING PHASE, IT WAS DISCOVERED THAT THE PATIENT'S TIBIA WAS DEVELOPING A SLIGHT PROCURVATUM DEFORMITY; HOWEVER IT WAS DECIDED TO CONTINUE WITH THE LENGTHENING PROCESS. DURING REMOVAL OF THE PLATE AFTER LENGTHENING HAD REACHED AN ACCEPTABLE RESULT, ONE OF THE 4.5MM LOCKING SCREWS IN THE DISTAL SEGMENT OF THE PLATE WAS NOTED TO BE BROKEN AND IT WAS ALSO DISCOVERED THAT THE SCREW HAD BEEN IMPLANTED WITH PURCHASE IN THE NEAR CORTEX ONLY. ADDITIONALLY, IT WAS REPORTED THE PLATE HAD BEEN IMPLANTED IN AN INVERTED ORIENTATION. THE SURGEON MADE ALIGNMENT ADJUSTMENTS AND REINFORCED THE SURGICAL SITE WITH A STATIC LOCKING PLATE. REPORT 1 OF 2.
Patient problems: Deformity/ Disfigurement
MAUDE report 11589047 ↗MalfunctionFeb 22, 2021Defective Device; Defective Device
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 FOR LOSS OF CORRECTION. AS PER THE REPORTER, AFTER A X-RAY ASSESSMENT, IT WAS DISCOVERED THAT THE PROXIMAL SCREW CLUSTER LOST PURCHASE IN THE PROXIMAL BONE SEGMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11363726 ↗
Other Nuvasive Specialized Orthopedics, Inc. products
- MAGEC Spinal Bracing and Distraction System29 models · 663 reports · 1 recall
- PRECICE Intramedullary Limb Lengthening System551 models · 177 reports · 4 recalls
- PRECICE STRYDE System231 models · 139 reports · 2 recalls
- PRECICE Bone Transport System561 models · 28 reports · 3 recalls
- PRECICE Plating System67 models · 24 reports · 3 recalls
- PRECICE Trauma Nail System182 models · 4 reports · 3 recalls
- FREEDOM Residual Limb Lengthening System2 models · 1 reports · 2 recalls
- PRECICE System15 models · 0 reports · 1 recall
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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