Meridian RA2-003015Recalls & reported problems
Seaspine Orthopedics Corporation · Angled Awl Fixed · Class 1
All models of Meridian (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981216368), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 4, 2024Open, Classified
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Z-2357-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Integrity 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.
MalfunctionApr 23, 2024Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY WITH SEASPINE'S MERIDIAN INTERBODY SYSTEM. SEASPINE RECEIVED A COMPLAINT REGARDING THE MERIDIAN ANGLED AWL FIXED. DURING SCREW PLACEMENT, THE WELD OF THE ANGLED AWL FRACTURED, WHICH SUBSEQUENTLY PREVENTED THE IMPLANTATION OF THE 2 L5 SCREWS BECAUSE THE STRAIGHT AWL COULD NOT ACHIEVE THE REQUIRED ANGLE. AS A RESULT, THE SURGEON PROCEEDED WITH ONLY 1 SCREW IN S1 AND NO L5 FIXATION, OPTING TO USE PERCUTANEOUS PEDICLE SCREWS POSTERIORLY INSTEAD, LEADING TO A 30-MINUTE PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19168538 ↗
Other AWL devices
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 reports
- NA 03.010.040Synthes GmbH · AWL4 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 · each recall links to the FDA recall notice
- 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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