Device product
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.
Z-1482-2013
Product summary
- Event
- Event 64991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-1482-2013
Official wording
Reason: During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Code information: Lot number: 20856
Distribution pattern: Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Derived failure modes
-
Unknown
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.