The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0127-2014·Announced 2013-11-13

Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk

Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II. The hazard involves a device fracture that could require additional medical intervention, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the Dekompressor Percutaneous Discectomy Probe. This single-use disposable device is used in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material. The recall involves 20,385 units distributed nationwide since 2004, including in Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Mississippi, North Dakota, and Nebraska. Affected part numbers are 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.

The recall was initiated because Stryker identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device, which may result in a fracture of the auger and/or cannula.

If the device fractures, it could result in the need for additional medical intervention to remove the broken piece, as well as pain or loss of motion. Healthcare providers should stop using the affected devices and contact Stryker for further instructions.

The recalled product

Product
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Orthopedic / Spinal
Hazard

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 (6)

  • Part Number(s) 0407-251-000
  • 0407-260-000
  • 0407-265-000
  • 0407-266-000
  • 0407-280-000
  • and 0407-281-000.

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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