DJO SURGICAL 506-03-126Recalls & reported problems
Encore Medical, L.P. · SCREW, LOCKING BONE, RSP, 5X26 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912024563), received between Mar 28, 2018 and May 15, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K041066); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Loose or Intermittent Connection1
Patient problems
- Fall1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Radiolucent Lines1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO RADIOLUCENT LINE BY THE POATIERIOR.
Patient problems: Radiolucent Lines
MAUDE report 22024619 ↗InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BROKEN SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16015373 ↗InjuryDec 6, 2019Loose or Intermittent Connection
PRIMARY SURGERY - THE SCREW WOULD NOT LOCK INTO PLATE. OPENED AND USED ANOTHER SCREW, AND IT ENGAGED AND LOCKED INTO THE BASEPLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9434537 ↗InjuryMar 28, 2018Break
REVISION SURGERY - DUE TO THE PATIENT HAVING A TREMENDOUS FALL AND BREAKING SEVERAL IMPLANTS INSIDE OF THEM. THE REPRESENTATIVE INDICATED THAT THERE IS A SCREW FROM THE BASEPLATE STILL INSIDE THE PATIENT.
Patient problems: Fall; No Code Available
MAUDE report 7379621 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041066. One submission often covers many models, so check the product and lot details in each record.
- Z-0098-2024 · Aug 22, 2023 · Open, ClassifiedREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- Z-0185-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-0184-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-1566-05 · Jul 28, 2005 · TerminatedEncore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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