FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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.
- Recall number
- Z-1957-2013
- Recalling firm
- SpineFrontier, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-05-09
- Posted
- 2013-08-13
- Terminated
- 2014-01-10
- Reason
- The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
- Root cause
- Device Design
- Action
- On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.
- Quantity
- 9
- Distribution
- Distributed in DC and the states of MA, and OK.
- Lot, serial or model codes
- Lot Number: 011836-0001, 011981-001
- 510(k) numbers
- ["K121060"]
- PMA numbers
- not on file
- Product code
- HXX
- 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