Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number:

FDA device recall Z-1808-2013 · posted 2013-07-25 · Terminated

Recall details

Recalling firm

Stryker Neurovascular

Reason for recall

The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).

Action taken

Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.

Root cause

Packaging process control

Status

Terminated

Product code

NJE

Quantity affected

23 units

Distribution

International Distribution including Austria, China, and Germany.

Date initiated

2013-06-24

Date posted

2013-07-25

Date terminated

2013-09-30

Location

Fremont, CA