Z-1957-2013 Class II Terminated
FDA device recall Z-1957-2013 was initiated by SpineFrontier, Inc. on May 9, 2012 and is designated Class II. Reason for recall: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. The recall status is terminated (terminated Jan 10, 2014). Affected quantity: 9.
Recall details
- Product Type
- Devices
- Report Date
- Aug 21, 2013
- Initiation Date
- May 9, 2012
- Termination Date
- Jan 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product description
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Reason for recall
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Distribution pattern
Distributed in DC and the states of MA, and OK.
Code information
Lot Number: 011836-0001, 011981-001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1957-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026