NA 04.112.623Recalls & reported problems
Synthes GmbH · 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ RIGHT · Class 2 · Implant
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 10886982278982), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K201321, K203414); 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
InjuryJul 19, 2023Break; Break
IT WAS FURTHER REPORTED THAT PSEUDARTHROSIS WITH FRACTURE OF ALL 5 MEDIAL ANGLE-STABLE SCREWS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture
MAUDE report 17353539 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201321, K203414. One submission often covers many models, so check the product and lot details in each record.
- Z-1241-2024 · Jan 24, 2024 · Open, ClassifiedVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
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.
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