OPTILINK 42.231.655Recalls & reported problems
Synthes GmbH · 5.0MM CANN VAL SCREW OPTILINK(TM)/55MM · Class 2 · Implant
All models of OPTILINK (11)
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 10886982259110), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
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.
MalfunctionMar 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE VA CANN-LOCK-SCRØ5.0 OPTILINK TECHN L65 ARRIVED IN THE CORRECT PACKAGING, BUT INSIDE WAS AN INCORRECT SCREW SIZE. DUE TO THE PACKAGING BEING CORRECT, IT WAS OPENED AND THEN DISCOVERED TO BE THE WRONG SIZE SCREW INSIDE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM CANN VAL SCREW OPTILINK(TM)/55MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928617 ↗
Other Cerclage, fixation devices
- ZipFix 03.501.080Synthes GmbH · CERCLAGE, FIXATION236 reports
- CONTROL 1739-28-000Depuy Orthopaedics, Inc. · CERCLAGE, FIXATION52 reports
- Dall-Miles 6704-0-110Howmedica Osteonics Corp. · CERCLAGE, FIXATION1 recall1 report
- Tritium® Sternal Cable Plate System 86-27-12-S12Pioneer Surgical Technology, Inc. · CERCLAGE, FIXATION1 recall0 reports
- Accord 71340007Smith & Nephew, Inc. · CERCLAGE, FIXATION47 reports
- ZipFix 08.501.001.01SSynthes GmbH · CERCLAGE, FIXATION39 reports
- NA 298.801.01SSynthes GmbH · CERCLAGE, FIXATION33 reports
- ZipFix 08.501.001.05SSynthes GmbH · CERCLAGE, FIXATION29 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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