Z-1482-2013 Class II Terminated
FDA device recall Z-1482-2013 was initiated by SpineFrontier, Inc. on May 10, 2008 and is designated Class II. Reason for recall: During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 10.
Recall details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- May 10, 2008
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product description
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Reason for recall
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Distribution pattern
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Code information
Lot number: 20856
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1482-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026