—#131299

Product

GDC-10 360 10mm x 30cm 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

FDA product code: HCG — Device, Neurovascular Embolization
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K103355
Affected lot / code info: Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013.

Why it was recalled

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Root cause (FDA determination)

Process control

Action the firm took

Stryker 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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: US Distribution to the states of: VA, NH, OH and TX.

Timeline

Recall initiated: 2014-10-22
Posted by FDA: 2014-12-16
Terminated: 2015-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.