FDAClass IIApril 27, 2016

GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile recall

GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for…

Why was GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile recalled?

The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.

Product
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for…
Recalling firm
Stryker Neurovascular
Quantity
316 total, both models
Distribution
Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
Recall date
April 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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