A.L.P.S.® Clavicle Plating System 133525110Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868455377), received between May 23, 2022 and May 23, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K173767); 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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON TRIED TO BEND THE STANDARD SUPERIOR PLATE AND IT BROKE ON THE END OF THE PLATE, THE SURGEON HAD TO MAKE A LONGER INCISION FOR A LONGER PLATE AND THAT ADDED ADDITIONAL TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468875 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173767. One submission often covers many models, so check the product and lot details in each record.
- Z-0882-2021 · Dec 23, 2020 · TerminatedA.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle incl
- Z-2308-2020 · May 14, 2020 · TerminatedA.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fracture
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-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive 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-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 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