Recall Z-1655-2009 ยท MNI Orthosis, Spinal Pedicle Fixation
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.
| Date | Jul 6, 2009 (initiated May 21, 2009) |
| Status | Terminated |
| Reason | Product marketed without an approved 510(k) |
| Root cause | Finished device change control |
| 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. |
| Quantity | 63 implant kits, 80 instrument kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042514 | MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM Blackstone Medical, Inc., Oct 7, 2004 |