Peri-Loc 71802608Recalls & reported problems
Smith & Nephew, Inc. · PERI-LOC 3.5MM LOCKING RECON PLATE 8 HOLE 94MM · Class 2 · Implant
All models of Peri-Loc (102)
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 03596010585028), received between May 14, 2019 and May 14, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination 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
- Contamination /Decontamination Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING SURGERY THE TRANSPARENT WRAPPING WAS OPEN WHILE THE OUTSIDE PACKAGE WAS GOOD. DELAY FROM MORE THAN AN HOUR REPORTED. OPENED THE SECOND PRODUCT IN THE CASE WITH THE SAME FAILURE MODE WHICH WAS RESTERILIZED AND USED AND WITH IT COMPLETED THE SURGERY. NO IMPACT OR INJURY TO PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609890 ↗
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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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