Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174,
FDA device recall Z-1794-2015 · posted 2015-06-12 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
- Action taken
- Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 18
- Distribution
- US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
- Date initiated
- 2015-05-05
- Date posted
- 2015-06-12
- Date terminated
- 2015-07-02
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION PASSIVE INSTRUMENT OPTION (K972398) | Surgical Navigation Technologies, Inc. | 1997-09-16 |