Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-903
FDA device recall Z-1655-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Blackstone Medical, Inc.
- Reason for recall
- Product marketed without an approved 510(k)
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 63 implant kits, 80 instrument kits
- Distribution
- Nationwide
- Date initiated
- 2009-05-21
- Date posted
- 2009-07-06
- Date terminated
- 2015-04-07
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM (K042514) | Blackstone Medical, Inc. | 2004-10-07 |