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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Blackstone Medical Inc.
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Blackstone Medical Inc. is recalling ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) It due to Pedicle Screw may disengage in post op period requiring intervention. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pedicle Screw may disengage in post op period requiring intervention
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, IL, NH, NM, TX
Page updated: Jan 10, 2026