Z-0127-2014 Class II Terminated
FDA device recall Z-0127-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on Nov 4, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 29, 2014). Affected quantity: 20,385 total distributed since 2004.
Recall details
- Product Type
- Devices
- Report Date
- Nov 13, 2013
- Initiation Date
- Nov 4, 2013
- Termination Date
- Apr 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,385 total distributed since 2004
Product description
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.
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
Distribution pattern
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Code information
Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0127-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026