P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIV
FDA device recall Z-2823-2015 · posted 2015-09-30 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
- Action taken
- Medtronic sent an Urgent Medical Device Correction Notification letter dated September 14, 2015, to all affected consignees via FedEx. Revised Instructions for Use were provided to add additional warnings related to the careful inspection of the instruments and the importance of knowledge of operating procedures, patient selection, and product information. Consignees with questions were instructed to to call the local Medtronic Navigation Technical Services Representative or call 1-800-995-9709.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 2,346
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; I
- Date initiated
- 2015-09-14
- Date posted
- 2015-09-30
- Date terminated
- 2015-12-03
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS (K124004) | Medtronic Navigation, Inc. | 2013-03-22 |