A.L.P.S.® 8561-35-026Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868351884), received between Jun 25, 2025 and Aug 25, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Discomfort1
- Erythema1
- Insufficient Information1
- Purulent Discharge1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that after fixation with a plate system, erythema and purulent drainage developed around the plate and the patient reported discomfort; the plate was subsequently removed approximately five months post-implantation. Concerns were raised by sales and dealership staff regarding the hospital¿s sterilization and cleaning facilities; however, the validity of these concerns was unclear.Attempts have been made and no further information has been provided.
Patient problems: Discomfort; Erythema; Purulent Discharge
MAUDE report 50430133 ↗MalfunctionJun 25, 2025Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY FOUR (4) MONTHS AFTER A SHOULDER PROCEDURE, THE PLATING SYSTEM MIGRATED FROM ITS INTENDED POSITION AND THE DISTAL PORTION OF THE PLATE MAY HAVE LIFTED. NO REVISION SURGERY IS PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22330753 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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.
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