Z-1869-2013 Class II Terminated
FDA device recall Z-1869-2013 was initiated by SpineFrontier, Inc. on Oct 5, 2012 and is designated Class II. Reason for recall: Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm… The recall status is terminated (terminated Jul 29, 2015). Affected quantity: 11 caddies.
Recall details
- Product Type
- Devices
- Report Date
- Aug 7, 2013
- Initiation Date
- Oct 5, 2012
- Termination Date
- Jul 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 caddies
Product description
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Reason for recall
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Distribution pattern
US distribution in states of: CO, DC, MA and TX.
Code information
31176, 018652, 018645R, 42011
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1869-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026