Peri-Loc 71801010Recalls & reported problems
Smith & Nephew, Inc. · 3.5MM MED DISTAL TIBIA LOCKING PLATE 10 HOLE LEFT 185MM · Class 2 · Implant
All models of Peri-Loc (102)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010520616), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K092015, K210837, K213126); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW "EFFECT OF SURGICAL FIXATION ON THE RATE OF FRACTURE HEALING AND BONE DENSITY OF PAHENTT WITH OPEN AND COMMINUTED FRACTURE OF EXTREMITIES", 3 PATIENTS HAD A BONE NONUNION AFTER A PROCEDURE FOR FRACTURE TREATMENT USING A PERI-LOC PERIARTICULAR LOCKING PLATING SYSTEM. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. PATIENTS OUTCOME ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18544972 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092015, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.
- Z-2036-2017 · Mar 22, 2017 · TerminatedPERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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