Z-0624-2014 Class II Terminated
FDA device recall Z-0624-2014 was initiated by SpineFrontier, Inc. on Sep 11, 2013 and is designated Class II. Reason for recall: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 13 devices.
Recall details
- Product Type
- Devices
- Report Date
- Jan 15, 2014
- Initiation Date
- Sep 11, 2013
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
Product description
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Reason for recall
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Distribution pattern
US Distribution: including states of: TX and VA.
Code information
Lot: 012212-001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0624-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026