Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inser
FDA device recall Z-1482-2013 · posted 2013-06-05 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
- Action taken
- Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HWA
- Quantity affected
- 10
- Distribution
- Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
- Date initiated
- 2008-05-10
- Date posted
- 2013-06-05
- Date terminated
- 2014-10-08
- Location
- Beverly, MA
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