The Recall Desk
HighFDA (Devices)·Z-1972-2023·Announced 2023-06-21

Driver Instrument May Break During Surgery, Leaving Metal Fragments

The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. However, the device failure (instrument tip breakage) may result in retained metal fragments at the surgical site with potential serious patient safety implications, including MRI contraindication. Meets 'High' severity as a risk-of-harm product without yet-reported injuries.

Plain-English summary

The Superion Indirect Decompression System's Driver Instrument (part number 102-9800) may fracture during surgical implantation if excessive force is applied. When the driver tips break, metal fragments may remain at the implant location.

If metal fragments are not completely removed and remain in the patient's body, MRI scans are contraindicated due to potential patient injury risks associated with retained metal implants.

Boston Scientific is updating the product's instructions for use to inform surgical teams about the risk of excessive force during implantation causing driver tip breakage and to emphasize the critical importance of verifying complete removal of any metal fragments before closing the surgical site.

The driver instrument (UDI-DI: 00884662000574, UPN: 102-9800, all lots) has been distributed nationwide. Surgeons and surgical teams should review the updated instructions and ensure that any metal fragments are completely removed from the surgical site before completing the procedure.

The recalled product

Product
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Manufacturer
Boston Scientific Neuromodulation Corporation
Category
Medical Device — Spinal Surgery Instrument
Hazard
  • instrument-breakage
  • retained-metal-fragments

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Driver UDI-DI: 00884662000574
  • UPN: 102-9800
  • All Lots. Superion Indirect Decompression System IFU (92479815-02)
  • Superion IDS Kit IFU (92479820-02)
  • Surgical Technique Manual (92479821-02)

Distribution

Distributed nationwide across the United States.

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