Z-1655-2009

Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case#...

Name: Z-1655-2009 Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case#...
Creator: Blackstone Medical, Inc.
Published: 2009-05-21
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2009-05-21 / Terminated

FDA source

Blackstone Medical, Inc. began a recall of 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 on 2009-05-21. The reason FDA records is "Product marketed without an approved 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1655-2009
Status: Terminated
Initiated: 2009-05-21
Posted: 2009-07-06
Terminated: 2015-04-07
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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Product marketed without an approved 510(k)
FDA 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 in commerce: 63 implant kits, 80 instrument kits
Distribution: Nationwide
Product codes and lots: All lots

Product code MNI

K042514Class IIModification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc. / cleared 2004-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)