FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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.
- Recall number
- Z-1482-2013
- Recalling firm
- SpineFrontier, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-05-10
- Posted
- 2013-06-05
- Terminated
- 2014-10-08
- Reason
- During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
- Root cause
- Process design
- Action
- Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution.
- Quantity
- 10
- Distribution
- Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
- Lot, serial or model codes
- Lot number: 20856
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28