FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
- Recall number
- Z-0575-2014
- Recalling firm
- SpineFrontier, Inc.
- Product
- Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
- Status
- Terminated
- Initiated
- 2013-11-20
- Posted
- 2013-12-26
- Terminated
- 2018-09-06
- Reason
- Mismarked and unmarked screws
- Root cause
- Packaging process control
- Action
- On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.
- Quantity
- not on file
- Distribution
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- Lot, serial or model codes
- Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
- 510(k) numbers
- ["K121060"]
- PMA numbers
- not on file
- Product code
- KWQ
- 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