DARCO DCS2832020Recalls & reported problems
Wright Medical Technology, Inc. · Bow II Opening Wedge Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420112101), received between Jan 12, 2022 and Jan 12, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2022Nonstandard Device; Connection Problem; Nonstandard Device; Connection Problem
AN OSTEOTOMY OF THE TOE WAS PERFORMED ON A PATIENT WITH A BUNION. WHEN THE PLATE WAS FASTENED, IT WAS NOTICED THAT TWO OF THE FOUR LOCKING HOLES WERE NOT THREADED, AND THE LOCKING SCREWS COULD NOT BE USED. THE PLATE WAS USED AS IT WAS WITHOUT REPLACEMENT, BUT THE TWO HOLES WERE FIXED WITH A NON-LOCKING SCREW, AND THE SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13239359 ↗
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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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