Z-1516-2016Class II

GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360...

Name: Z-1516-2016 GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360...
Creator: Stryker Neurovascular
Published: 2016-03-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-03-21 / Terminated / root cause: packaging

FDA source

Stryker Neurovascular began a recall of GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of... on 2016-03-21. FDA classified it as Class II and gives the reason as "The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1516-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Posted: 2016-04-19
Terminated: 2016-07-05
Recalling firm: Stryker Corp.
Product: 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 code: HCG Device, Neurovascular Embolization
Reason for recall: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to. Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: [email protected]
Quantity in commerce: 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.
Product codes and lots: Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1516-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1516-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19
Z-1517-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

Product code HCG

K042539Class IIGdc-10 360 Degree Coil Sr; Gdc-10 360 Degree Soft Coil Sr; Gdc-18 360 Degree CoilBoston Scientific Corp / cleared 2004-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)