Z-1932-2013 Class II Terminated
FDA device recall Z-1932-2013 was initiated by SpineFrontier, Inc. on Aug 29, 2012 and is designated Class II. Reason for recall: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. The recall status is terminated (terminated Oct 18, 2013). Affected quantity: 11.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Aug 29, 2012
- Termination Date
- Oct 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product description
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Reason for recall
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Distribution pattern
US Distribution including the states of MA, NV and TX.
Code information
Lot Numbers: 1335201A, 1446101A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1932-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026