CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report
Dekompressor Percutaneous Discectomy Probe recalled
Stryker Instruments Div. of Stryker is recalling Dekompressor Percutaneous Discectomy Probe, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0127-2014
- FDA event ID
- 66456
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2013
- FDA classified
- 1 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Nov 2013 | Classified by FDA | |
| 4 Nov 2013 | Recall initiated by company | +3 days |
| 13 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has 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 and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasMississippiNorth DakotaNebraska
Questions about this recall
Is Dekompressor Percutaneous Discectomy Probe recalled?
Yes. Stryker Instruments Div. of Stryker recalled Dekompressor Percutaneous Discectomy Probe on 4 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0127-2014.
Why was it recalled?
Stryker has 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 and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m
Which lots are affected?
Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.
Where was it sold?
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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