FDA Medical Device Recalls (openFDA)
Medtronic Neurosurgery: Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
- Recall number
- Z-0849-06
- Recalling firm
- Medtronic Neurosurgery
- Product
- Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
- Status
- Terminated
- Initiated
- 2006-03-08
- Posted
- 2006-05-06
- Terminated
- 2008-06-26
- Reason
- Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.
- Root cause
- Other
- Action
- Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each Medtronic Sales Representative who has received the product or is responsible for an account who has received the product. This letter requests the current product status, i.e., has the product been used, discarded or will it be returned to Medtronic Neurosurgery. Each letter will be individualized for each customer indicating the specific catalog number(s), lot number(s) and quantity that were shipped to that customer. It is the firm''s intention to have the Sales Representative exchange all affected product with replacement product during this process.
- Quantity
- 60
- Distribution
- The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee
- Lot, serial or model codes
- TV 59965, TV 59967
- 510(k) numbers
- ["K974017"]
- PMA numbers
- not on file
- Product code
- GXL
- Firm FEI
- 3015531529
- Firm city
- Goleta
- Firm state
- CA
- 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