MEDLINE UNITERecalls & reported problems across all models
Medline Industries, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MEDLINE UNITE 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
- 5
- Recalls
- 1
We found 10 models of MEDLINE UNITE by Medline Industries, 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 4, 2019 and Sep 10, 2026 — classified as 5 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
MEDLINE UNITE 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.
- Dec 22, 2022Open, Classified
The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.
Z-1047-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported MEDLINE UNITE problems
Device problems
- Break5
- Migration2
- Device Dislodged or Dislocated1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient2
- Failure of Implant1
- No Information1
- No Known Impact Or Consequence To Patient1
MEDLINE UNITE models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MEDLINE UNITE MPN10013REAMER1 recall0 reports
- MEDLINE UNITE MPPA508UPlate, fixation, bone1 report
- MEDLINE UNITE MPPA401RPlate, fixation, bone1 report
- Medline UNITE MPP1001RPlate, fixation, bone1 report
- Medline UNITE MPP1005RPlate, fixation, bone1 report
- MEDLINE UNITE MFSL2412Screw, fixation, bone1 report
- MEDLINE UNITE MPN10019REAMER1 report
- MEDLINE UNITE MPP8101UPlate, fixation, bone1 report
- MEDLINE UNITE MPP8602LPlate, fixation, bone1 report
- MEDLINE UNITE MPSX3534Screw, fixation, bone1 report
Recent MEDLINE UNITE adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716642 ↗InjuryJul 12, 2023Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023, WHEN INSERTING THE SCREW TO CORRECT A "METATARSAL FRACTURE" THE "SCREW HEAD BROKE OFF" WHILE BEING TIGHTENED INTO THE PLATE.
Patient problems: Foreign Body In Patient
MAUDE report 17308285 ↗InjuryMay 26, 2022Break
ACCORDING TO THE FACILITY DURING A PROCEDURE THE 'DRILL BIT BROKE INSIDE THE PATIENT AND HAD TO BE REMOVED BY THE PHYSICIAN'.
Patient problems: Foreign Body In Patient
MAUDE report 14516621 ↗InjuryDec 14, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CROSS PLATE SCREW WAS BACKING OUT OF THE LAPAIDUS PLATE IN THE PATIENTS FOOT REQUIRING REMOVAL BY THE CLINICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13001018 ↗MalfunctionJul 13, 2021Migration
IT WAS REPORTED, "SCREWS WENT THROUGH PLATE TWO YEARS AFTER IMPLANTATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12163350 ↗InjuryApr 5, 2021Migration
IT WAS REPORTED THAT 2 SCREWS WERE FOUND TO HAVE GONE THROUGH THE POSTEROLATERAL TIBIA PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613129 ↗MalfunctionMar 17, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE END USER HE HAD TO HAVE SURGERY TO REMOVE A BROKEN PLATE.
Patient problems: Failure of Implant
MAUDE report 11506142 ↗MalfunctionApr 5, 2019Break
IT WAS REPORTED THAT DURING A PATIENT'S THREE MONTH FOLLOW UP VISIT WITH THE DOCTOR THE IMPLANTED METATARSAL-PHALANGEAL JOINT (MTP) FUSION PLATE WAS NOTED DURING X-RAY TO BE BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8486594 ↗InjuryFeb 4, 2019Break
IT WAS REPORTED THAT DURING ROUTINE PATIENT FOLLOW UP THE IMPLANTED PLATE WAS BROKEN.
Patient problems: No Information
MAUDE report 8302789 ↗
Other Medline Industries, Inc. products
- Centurion Medical Products Corp52 models · 10 reports · 32 recalls
- NAMIC667 models · 229 reports · 22 recalls
- CURAD85 models · 295 reports · 4 recalls
- HUDSON RCI30 models · 190 reports · 2 recalls
- Excelsior8 models · 47 reports · 3 recalls
- BAUSCH and LOMB6 models · 1 reports · 2 recalls
- Medline ReNewal18 models · 34 reports · 1 recall
- Guardian15 models · 77 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page