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U.S. Department of Health and Human Services

Class 2 Device Recall GDC10 360 SOFT 3mm x 6cm SR:

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 Class 2 Device Recall GDC10 360 SOFT 3mm x 6cm SR:see related information
Date Initiated by FirmOctober 22, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on February 12, 2015
Recall NumberZ-0478-2015
Recall Event ID 69669
510(K)NumberK103355 
Product Classification Device, neurovascular embolization - Product Code HCG
ProductGDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's 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
Code Information Model M003347306SRO, Lot number: 14467382; Exp. May 2014.
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactGary Rebman
510-413-2263
Manufacturer Reason
for Recall		Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
FDA Determined
Cause 2		Process control
ActionStryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: NeuroComplaints@stryker.com c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.
Quantity in Commerce1
DistributionUS Distribution to the states of: VA, NH, OH and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HCG
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