DJO SURGICAL 508-00-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912024617), received between Sep 20, 2016 and Sep 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K051075); 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  REVISION SURGERY - DUE TO WHEN INSERTING THE SET SCREW INTO THE GLENOSPHERE WITH THE RED HANDLE TORQUE SCREWDRIVER THE SCREW BROKE OFF HALFWAY. BROKEN/FRAGMENTED PIECES LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20274343 ↗
• InjuryJan 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENT FAILURE - PIECES LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18531774 ↗
• InjuryMay 16, 2017Break; Detachment Of Device Component

  PRIMARY SURGERY - WHILE THE SURGEON WAS TURNING THE SCREW, IT OVER TORQUED AND THE HEAD OF THE SCREW SNAPPED OFF. THE SCREW IS NOT IN THE PATIENT BUT THE REMAINING SHAFT OF THE SCREW STAYED IN THE BASEPLATE/GLENOSPHERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6569407 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT PRESENTING AFTER A REVISION IN PAIN AND INFECTED. THE SURGEON DECIDED TO GO IN AND REMOVE ALL THE GLENOID COMPONENTS, THE 44 POLY AS WELL AS THE +8 SPACER. HE THEN DECIDED TO PUT IN A HEMI SPACER AND A HEMI HEAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 5963635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051075. One submission often covers many models, so check the product and lot details in each record.

• Z-1460-2026 · Jan 15, 2026 · Open, Classified
  Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
• Z-0625-2024 · Oct 5, 2023 · Completed
  Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
• Z-0282-2024 · Sep 25, 2023 · Open, Classified
  RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
• Z-2606-2023 · Aug 4, 2023 · Open, Classified
  DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst
• Z-2739-2011 · Apr 18, 2011 · Terminated
  Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prost