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
FDA Recall Z-0716-06 · Posted 2006-04-19
Recalling FirmBlackstone Medical Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2005-12-23
Date Terminated2013-04-09
Product Quantity23 sets
Reason for Recall
Pedicle Screw may disengage in post op period requiring intervention
Firm 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.
Root Cause
Device Design
Distribution Pattern
AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.