Z-0622-2018 Class II Terminated
FDA device recall Z-0622-2018 was initiated by Medtronic Neurosurgery on December 20, 2017 and is designated Class II. Reason for recall: Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. The recall status is terminated (terminated December 8, 2023). Affected quantity: 27,432.8 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- December 20, 2017
- Termination Date
- December 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,432.8 devices
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.
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
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