Recall Z-0622-2018— Medtronic Neurosurgery
Class II · Terminated
Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2017-12-20, terminated 2023-12-08. It names one FDA 510(k) clearance: K050044. Product: Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10). Reason: Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-20
- Terminated
- 2023-12-08
- Firm location
- Goleta, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
Reason for recall
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
Data sourced from openFDA. This site is unofficial and independent of the FDA.