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.
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: 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
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
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