DJO SURGICAL 804-09-027Recalls & reported problems
Encore Medical, L.P. · ALTIVATE ANATOMIC AG, HALF WEDGE REAMING GUIDE, 5MM, RIGHT · Class 2
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 00190446729105), received between Jan 6, 2026 and Jan 6, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Mechanical Problem
COMPLAINT - COLD WELDED THE SHORT PINS INTO ALL 4 GUIDES, 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23986235 ↗InjuryJan 6, 2026Mechanical Problem
COMPLAINT - COLD WELDED THE SHORT PINS INTO ALL 4 GUIDES, 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23986234 ↗InjuryJan 6, 2026Mechanical Problem
COMPLAINT - COLD WELDED THE SHORT PINS INTO ALL 4 GUIDES, 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23986233 ↗InjuryJan 6, 2026Mechanical Problem
COMPLAINT - COLD WELDED THE SHORT PINS INTO ALL 4 GUIDES, 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23986228 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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