GRAVITY 86PK2027Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420193711), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2023Break; Fracture; Break; Fracture
DURING INSERTION, THE LOWER HALF OF THE ANCHOR BROKE OFF. THE COMPLAINT PRODUCT CANNOT BE RETURNED, AND NO IMAGES ARE AVAILABLE. THE PROCEDURE WAS DRIVEN BY THE CLINICAL REASONS OF ANKLE INSTABILITY AND DEBRIDEMENT. THERE WERE NO MEDICAL INTERVENTIONS OR SURGICAL DELAYS, AND NO ADDITIONAL ADVERSE EVENTS. DEBRIS WERE NOTED DURING THE PROCEDURE. HOWEVER, NOT ALL DEBRIS COULD BE REMOVED FROM THE PATIENT OR SURGICAL FIELD, AS THE OTHER HALF OF THE ANCHOR INSERTED INTO THE BONE COULD NOT BE OBTAINED. THE ISSUE WAS RESOLVED BY UTILIZING ANOTHER ANCHOR.
Patient problems: Foreign Body In Patient
MAUDE report 17542602 ↗
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- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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