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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Blackstone Medical, Inc.
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Blackstone Medical, Inc. is recalling Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instru due to Product marketed without an approved 510(k). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product marketed without an approved 510(k)
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026