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.
FDA Recall Z-1655-2009 · Posted 2009-07-06
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Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2009-05-21
Date Terminated2015-04-07
Product Quantity63 implant kits, 80 instrument kits
Reason for Recall
Product marketed without an approved 510(k)
Firm 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.
Root Cause
Finished device change control
Distribution Pattern
Nationwide
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.
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