Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-1516-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable.

Product Classification:

Class II

Date Initiated: March 21, 2016

Date Posted: April 27, 2016

Recall Number: Z-1516-2016

Event ID: 73705

Reason for Recall:

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

Status: Terminated

Product Quantity: 316 total, both models

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated