Z-0716-06

ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number...

Name: Z-0716-06 ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number...
Creator: Blackstone Medical Inc.
Published: 2005-12-23
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2005-12-23 / Terminated / root cause: design

FDA source

Blackstone Medical Inc. began a recall of ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number... on 2005-12-23. The reason FDA records is "Pedicle Screw may disengage in post op period requiring intervention". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0716-06
Status: Terminated
Initiated: 2005-12-23
Posted: 2006-04-19
Terminated: 2013-04-09
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
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Pedicle Screw may disengage in post op period requiring intervention
Root cause tag: design
FDA 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 in commerce: 23 sets
Distribution: AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
Product codes and lots: All lots

Product code KWQ

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)