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.
This recall has been terminated (originally issued July 6, 2009).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- May 21, 2009
- Posted
- July 6, 2009
- Terminated
- April 7, 2015
- Recall Number
- Z-1655-2009
- Quantity
- 63 implant kits, 80 instrument kits
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Product marketed without an approved 510(k)
Distribution
Nationwide
Lot / Code Info
All lots
Root Cause
Finished device change control
Action Taken
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.
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