DJO SURGICAL 506-03-130Recalls & reported problems
Encore Medical, L.P. · SCREW, LOCKING BONE, RSP, 5X30 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912024570), received between Apr 21, 2023 and Feb 18, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Unstable” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 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
Recalls naming this device
- Aug 22, 2023Class IIOpen, Classified
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Z-0098-2024 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Unstable2
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity2
- Bone Fracture(s)1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENT HAD CONTINUED SHOULDER PAIN
Patient problems: Pain
MAUDE report 24384448 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO HUMERUS FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 23365066 ↗InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERIPHERAL SCREWS WERE HITTING SUPRASCAPULAR NERVE.
Patient problems: Insufficient Information
MAUDE report 16827819 ↗InjuryApr 21, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
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-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 · each recall links to the FDA recall notice
- 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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