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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Clip Gun Scalp Clip

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 Class 2 Device Recall Medtronic Clip Gun Scalp Clipsee related information
Date Initiated by FirmDecember 20, 2017
Create DateFebruary 15, 2018
Recall Status1 Terminated 3 on December 08, 2023
Recall NumberZ-0622-2018
Recall Event ID 78997
510(K)NumberK050044 
Product Classification Clip, scalp - Product Code HBO
ProductModel #: 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)
Code Information Affected Lots: D80412, D84100, E00008, E00983, E03049, E03716, E05806, E07257, E09145, E14782, E14896, E15195, E19181, E19182, E19183, E19184, E19868, E20599, E23631, E33102, D80413, D84101, E00009, E00984, E03050, E03717, E05233, E05807, E07258, E09117, E09146, E09239, E11242, E11243, E11244, E11706, E12011, E12012, E13574, E14784, E14898, E15197, E19185, E19186, E19187, E19188, E19869, E20600, E23768, E23769, E23770, E23771, E23772, E23773, E23774, E33103, E33104, E33105, E33106, E33107, E33108, E33109, E33110, E33454, E34928, E05810, E09149, E19194, E19871, E23775, E33099
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Dr
Goleta CA 93117-3083
For Additional Information Contact
805-571-8400
Manufacturer Reason
for Recall		Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
FDA Determined
Cause 2		Package design/selection
ActionA Consignee Notification with response form was sent to affected consignees on 12/20/2017.
Quantity in Commerce27,432.8 devices
DistributionAlgeria, Armenia, Australia, Canada, Cyprus, Egypt, Germany, Ghana, Greece, Guam, Iceland, Indonesia, Iran, Italy, Jordan, New Zealand, Poland, Portugal, Puerto Rica, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, USA, Yemen
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBO
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