LCPRecalls & reported problems across all models
Synthes GmbH · 367 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,102
- Deaths reported
- 0
- Injuries reported
- 645
- Recalls
- 1
We found 367 models of LCP by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 1,102 adverse event reports in the FDA's MAUDE database, received between Dec 11, 2013 and Sep 29, 2026 — classified as 645 injuries, 457 malfunctions.
The most frequently reported specific device problem is “Break” (371 reports).
1 FDA recall record 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
LCP 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 21, 2020Class IITerminated
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
Z-2816-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported LCP problems
Device problems
- Adverse Event Without Identified Device or Use Problem405
- Break371
- Device-Device Incompatibility187
- Material Deformation41
- Material Twisted/Bent41
- Failure to Cut24
- Entrapment of Device23
- Migration21
Patient problems
- No Clinical Signs, Symptoms or Conditions314
- No Code Available200
- Nonunion/Delayed-union Bone Fracture170
- Unspecified Infection95
- Pain93
- Failure of Implant76
- No Consequences Or Impact To Patient60
- Insufficient Information55
LCP models
367 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- LCP 323.042Guide, surgical, instrument129 reports
- LCP 241.381PLATE, FIXATION, BONE1 recall14 reports
- LCP 324.214BIT, DRILL63 reports
- LCP 03.108.002Guide, surgical, instrument33 reports
- LCP 241.901APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT33 reports
- LCP 03.108.001Guide, surgical, instrument25 reports
- LCP SD242.003PLATE, FIXATION, BONE23 reports
- LCP 02.113.103PLATE, FIXATION, BONE21 reports
- LCP 241.351PLATE, FIXATION, BONE15 reports
- LCP 323.029Guide, surgical, instrument15 reports
- LCP 03.113.009GAUGE, DEPTH13 reports
- LCP 223.581APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT12 reports
- LCP 241.371PLATE, FIXATION, BONE12 reports
- LCP 241.401PLATE, FIXATION, BONE12 reports
- LCP 223.561Screw, fixation, bone11 reports
- LCP 241.361PLATE, FIXATION, BONE11 reports
- LCP 223.601APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT10 reports
- LCP 245.101APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT9 reports
- LCP 323.500Guide, surgical, instrument9 reports
- LCP 03.108.009Guide, surgical, instrument7 reports
- LCP 03.120.030ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- LCP 03.122.007Guide, surgical, instrument7 reports
- LCP 03.108.010Guide, surgical, instrument6 reports
- LCP 03.113.001Guide, surgical, instrument6 reports
- LCP 222.229PLATE, FIXATION, BONE6 reports
- LCP 223.571PLATE, FIXATION, BONE6 reports
- LCP 223.621Screw, fixation, bone6 reports
- LCP 224.591APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- LCP 226.622APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- LCP 245.061APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- LCP 245.081APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- LCP 247.372PLATE, FIXATION, BONE6 reports
- LCP 02.110.151PLATE, FIXATION, BONE5 reports
- LCP 02.112.530PLATE, FIXATION, BONE5 reports
- LCP 224.601Screw, fixation, bone5 reports
- LCP 241.094SPLATE, FIXATION, BONE5 reports
- LCP 241.903APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT5 reports
- LCP 242.531SPLATE, FIXATION, BONE5 reports
- LCP 247.374PLATE, FIXATION, BONE5 reports
- LCP 02.001.322APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- LCP 02.108.341Screw, fixation, bone4 reports
- LCP 02.112.080PLATE, FIXATION, BONE4 reports
- LCP 02.112.138PLATE, FIXATION, BONE4 reports
- LCP 02.112.518PLATE, FIXATION, BONE4 reports
- LCP 02.113.103SPLATE, FIXATION, BONE4 reports
- LCP 02.120.601PLATE, FIXATION, BONE4 reports
- LCP 03.120.001Guide, surgical, instrument4 reports
- LCP 03.120.005Guide, surgical, instrument4 reports
- LCP 223.591APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- LCP 226.641Screw, fixation, bone4 reports
- LCP 240.046PLATE, FIXATION, BONE4 reports
- LCP 241.421PLATE, FIXATION, BONE4 reports
- LCP 245.071APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- LCP 249.683PLATE, FIXATION, BONE4 reports
- LCP 313.353Guide, surgical, instrument4 reports
- LCP 02.001.306APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- LCP 02.104.010PLATE, FIXATION, BONE3 reports
- LCP 02.104.026PLATE, FIXATION, BONE3 reports
- LCP 02.110.150PLATE, FIXATION, BONE3 reports
- LCP 02.112.082PLATE, FIXATION, BONE3 reports
- LCP 02.112.093PLATE, FIXATION, BONE3 reports
- LCP 02.112.140Screw, fixation, bone3 reports
- LCP 02.112.141PLATE, FIXATION, BONE3 reports
- LCP 02.112.522PLATE, FIXATION, BONE3 reports
- LCP 02.112.527PLATE, FIXATION, BONE3 reports
- LCP 02.114.014PLATE, FIXATION, BONE3 reports
- LCP 03.111.905Screw, fixation, bone3 reports
- LCP 03.120.002Guide, surgical, instrument3 reports
- LCP 03.120.004Guide, surgical, instrument3 reports
- LCP 03.120.014Guide, surgical, instrument3 reports
- LCP 03.120.016Guide, surgical, instrument3 reports
- LCP 03.123.011Guide, surgical, instrument3 reports
- LCP 222.660PIN, FIXATION, THREADED3 reports
- LCP 223.551PLATE, FIXATION, BONE3 reports
- LCP 223.641Screw, fixation, bone3 reports
- LCP 224.561Screw, fixation, bone3 reports
- LCP 224.571PLATE, FIXATION, BONE3 reports
- LCP 224.621PLATE, FIXATION, BONE3 reports
- LCP 226.571APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- LCP 226.581Screw, fixation, bone3 reports
- LCP 226.591Screw, fixation, bone3 reports
- LCP 226.621PLATE, FIXATION, BONE3 reports
- LCP 226.682Screw, fixation, bone3 reports
- LCP 239.957PLATE, FIXATION, BONE3 reports
- LCP 240.042PLATE, FIXATION, BONE3 reports
- LCP 241.051APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- LCP 241.085SPLATE, FIXATION, BONE3 reports
- LCP 241.096SPLATE, FIXATION, BONE3 reports
- LCP 241.444APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- LCP 242.114PLATE, FIXATION, BONE3 reports
- LCP 245.121APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT3 reports
- LCP 247.360PLATE, FIXATION, BONE3 reports
- LCP 249.674PLATE, FIXATION, BONE3 reports
- LCP 249.684PLATE, FIXATION, BONE3 reports
- LCP 423.407APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE3 reports
- LCP 441.381PLATE, FIXATION, BONE3 reports
- LCP 02.001.300APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- LCP 02.001.322SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- LCP 02.001.324APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- LCP 02.104.008PLATE, FIXATION, BONE2 reports
Recent LCP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931500 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793122 ↗MalfunctionSep 16, 2026Break; Entrapment of Device
Patient problems: Foreign Body In Patient
MAUDE report 50793057 ↗MalfunctionSep 16, 2026Crack; Material Twisted/Bent; Illegible Information
It was reported during sterile processing it was identified that the Reduction instrument was deemed no longer functional due to non-legible item numbers, cracking handles, and stripped threading.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787424 ↗MalfunctionSep 15, 2026Crack; Material Twisted/Bent; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780280 ↗MalfunctionSep 1, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546476 ↗InjuryJul 30, 2026Break
It was reported that the plate ruptured, and the patient is scheduled for removal. One (1) Plate and eight (8) screws were used.
Patient problems: Insufficient Information
MAUDE report 50085251 ↗MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT WHEN THE DOCTOR DRILLED INTO THE CORTICAL BONE TO INSERT A LOCKING SCREW, HE APPLIED TOO MUCH FORCE, BREAKING THE TIP OF THE DRILL BIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536851 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT THE DRILL GUIDE FOR THE LOCKED SCREW IS BROKEN IN ITS THREADED PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448018 ↗InjuryMay 29, 2026Break
IT WAS REPORTED THAT A 4.5 LCP PROX FEMUR HOOK PL 14 H/349 EXPERIENCED A TRANSVERSE BREAK AT THE 5TH SHAFT HOLE. THE DEVICE WAS PLACED ON THE RIGHT SIDE TO TREAT A FRACTURE JUST DISTAL TO A HIP STEM. THE IMPLANT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE STATUS OF THE COMPLAINT DEVICE IS NOTED AS NOT AVAILABLE DUE TO IMPLANTATION AND SUBSEQUENT DISCARD.
Patient problems: Insufficient Information
MAUDE report 25335693 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED DRILL BIT WAS BROKEN ON AN UNKNOWN DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255363 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A PLATE AND A DRILL SLEEVE IN QUESTION. DURING THE SURGERY, THE SURGEON ATTEMPTED TO BEND THE PLATE IN A TWISTING DIRECTION WHILE THE DRILL SLEEVE WAS ATTACHED. TWO SURGEONS TRIED TO TWIST, AND THREAD PART OF THE DRILL SLEEVE BROKE. THERE WAS NO PART REMAINING IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY WITH THE REST OF THE DRILL SLEEVE USED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215185 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT TWO LOCKING GUIDES ARE IN BAD CONDITION. ONE HAS A BADLY DAMAGED THREAD THAT ATTACHES TO THE PLATES, AND THE OTHER BROKE DURING THE PROCEDURE. THE FRAGMENT WAS REMOVED AND PLACED IN THE CLINIC'S SHARPS CONTAINER. OTHER EQUIPMENT WAS USED. THERE WERE NO SETBACKS; THE SURGICAL PROCEDURE WAS NOT PROLONGED, AND IT WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149421 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT TWO LOCKING GUIDES ARE IN BAD CONDITION. ONE HAS A BADLY DAMAGED THREAD THAT ATTACHES TO THE PLATES, AND THE OTHER BROKE DURING THE PROCEDURE. THE FRAGMENT WAS REMOVED AND PLACED IN THE CLINIC'S SHARPS CONTAINER. OTHER EQUIPMENT WAS USED. THERE WERE NO SETBACKS; THE SURGICAL PROCEDURE WAS NOT PROLONGED, AND IT WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149418 ↗MalfunctionApr 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE AND LCP DRILL SLEEVE 2.4 W/SCAL-30 F/DRILL B WERE INVOLVED IN AN EVENT. DURING AN ORIF PROCEDURE FOR A DISTAL RADIUS FRACTURE, THE DRILL TIP BROKE OFF, LEAVING APPROXIMATELY 3 MM EMBEDDED IN THE CORTEX. THE TIP WAS EXTRACTED BY MAKING A DORSAL INCISION AND DISASSEMBLING THE AREA. THE DRILL GUIDE WAS DIFFICULT TO REMOVE, SUGGESTING IMPROPER FITTING DURING DRILLING, WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THERE WAS NO IMPACT TO THE EXPECTED SURGICAL OUTCOME, AND NO PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002055 ↗
Other Synthes GmbH products
All Synthes GmbH devices →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 18, 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