Equinoxe 300-30-14Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862515827), received between Aug 10, 2021 and Jun 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K162726); 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
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT RTSA. SUBSEQUENTLY, THE PATIENT EXPERIENCED A LOOSE STEM AND PAIN. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 9 DAYS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 22347788 ↗InjuryAug 10, 2021Fracture; Fracture
AS REPORTED, THIS (B)(6) MALE PATIENT EXPERIENCED A SCAPULAR SPINE FRACTURE (TYPE 2). SCAPULAR SPINE FRACTURE AFTER SHOULDER EXERCISES PERFORMED APPROXIMATELY 3 MONTHS POST-OP. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. A SLING APPLIED FOR TREATMENT AND ADVISED REST. OUTCOME IS REPORTED AS "CONTINUING". DEVICES REMAIN IN PLACE.
Patient problems: Bone Fracture(s)
MAUDE report 12303168 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162726. One submission often covers many models, so check the product and lot details in each record.
- Z-0958-2019 · Dec 5, 2018 · TerminatedEquinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohum
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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