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)
FDA Recall Z-0622-2018 · Posted None
Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeHBO
Date Initiated2017-12-20
Date Terminated2023-12-08
Product Quantity27,432.8 devices
Reason for Recall
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
Firm Action
A Consignee Notification with response form was sent to affected consignees on 12/20/2017.
Root Cause
Package design/selection
Distribution Pattern
Algeria, 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.