A.L.P.S.® 8561-35-010Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868351808), received between Nov 21, 2025 and Aug 25, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Biocompatibility” (2 reports).
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
- Biocompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction2
- Rash2
- Discomfort1
- Erythema1
- Purulent Discharge1
Recent adverse event reports
The 3 most recent of 3 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 50430432 ↗InjuryNov 21, 2025Biocompatibility; Biocompatibility
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PLATE AND NAIL SYSTEM PROCEDURE. THREE MONTHS POSTOPERATIVELY, ECZEMA DEVELOPED AROUND THE SURGICAL SITE, RAISING SUSPICION OF METAL ALLERGY. CONSEQUENTLY, ALL IMPLANTS WERE REMOVED. THE PATIENT IS LIKELY A POTENTIAL CARRIER OF METAL ALLERGIES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hypersensitivity/Allergic reaction; Rash
MAUDE report 23617990 ↗InjuryNov 21, 2025Biocompatibility; Biocompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Rash
MAUDE report 23617986 ↗
Other PIN, FIXATION, THREADED devices
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall2 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- APEX 5038-1-080Stryker GmbH · PIN, FIXATION, THREADED48 reports
- Agee Digit Widget® DWD-232Hand Biomechanics Lab Inc · Pin, Fixation, Threaded32 reports
- SPATIAL FRAME 71070720Smith & Nephew, Inc. · PIN, FIXATION, THREADED15 reports
- APEX 5038-2-110Stryker GmbH · PIN, FIXATION, THREADED11 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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