FDA Medical Device Recalls (openFDA)
Blackstone Medical Inc.: ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092
- Recall number
- Z-0716-06
- Recalling firm
- Blackstone Medical Inc.
- Product
- ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092
- Status
- Terminated
- Initiated
- 2005-12-23
- Posted
- 2006-04-19
- Terminated
- 2013-04-09
- Reason
- Pedicle Screw may disengage in post op period requiring intervention
- Root cause
- Device Design
- Action
- Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.
- Quantity
- 23 sets
- Distribution
- AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K042514"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3001238051
- Firm city
- Springfield
- 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