FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
- Recall number
- Z-2824-2015
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- 2015-09-30
- Terminated
- 2015-12-03
- Reason
- Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 2346
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; Slovakia; Turkey; and South Africa.
- Lot, serial or model codes
- For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015
- 510(k) numbers
- ["K050438"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28