A.L.P.S.® 8562-11-009Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868449765), received between Aug 25, 2022 and Oct 20, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (5 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.
Most reported problems
Device problems
- Packaging Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED DURING THE INCOMING INSPECTION AT ZB WAREHOUSE IN JAPAN A TEAM MEMBER FOUND THE STERILE PACKAGE WAS NOT VACUUMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15640448 ↗MalfunctionSep 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335679 ↗MalfunctionSep 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335674 ↗MalfunctionSep 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15335655 ↗MalfunctionAug 25, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15294167 ↗
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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