Off Axis Comp Mini Reamer Gd Med SSI005659Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024585256), received between May 15, 2024 and Mar 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K172502); 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT THE TIP OF THE INSTRUMENT FRACTURED. THE PIECE THAT FRACTURED FROM TIP OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587453 ↗MalfunctionMay 15, 2024Fracture; Fracture
IT WAS REPORTED THAT AN IMPACTOR AND REAMER WERE FRACTURED DURING A PROCEDURE. ALL FRAGMENTED PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETELY USING ADDITIONAL INSTRUMENTATION. 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 19321741 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172502. One submission often covers many models, so check the product and lot details in each record.
- Z-0520-2020 · Aug 21, 2019 · TerminatedCOMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM5
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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