ORTHOLOC 58813524Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
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 00840420114006), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate1
Patient problems
- Implant Pain1
- Loss of Range of Motion1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION (RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.
Patient problems: Implant Pain; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture
MAUDE report 16362676 ↗
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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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