Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self… recallZ-0849-06 · Medtronic Neurosurgery · initiated Mar 8, 2006
Terminated All recalls posted in May 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0849-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 8, 2006
- Posted by the FDA
- May 6, 2006
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 60
- Product code
- GXL
- FDA submissions
- K974017
- Distribution
- The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee
Product description
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.
Code information (models, lots, serial numbers)
TV 59965, TV 59967
Other devices under the same FDA submission
1 device cleared under K974017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CENTERPIECE™ Plate Fixation System 853-467Medtronic Sofamor Danek, Inc. · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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