FDA Medical Device Recalls (openFDA)
Blackstone Medical, Inc.: Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
- Recall number
- Z-1655-2009
- Recalling firm
- Blackstone Medical, Inc.
- Product
- Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
- Status
- Terminated
- Initiated
- 2009-05-21
- Posted
- 2009-07-06
- Terminated
- 2015-04-07
- Reason
- Product marketed without an approved 510(k)
- Root cause
- Finished device change control
- Action
- Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009.
- Quantity
- 63 implant kits, 80 instrument kits
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K042514"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3001238051
- Firm city
- Wayne
- Firm state
- NJ
- 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