Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the st

FDA device recall Z-0114-2014 · posted 2013-10-30 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.

Action taken

Synthes sent a Urgent Medical Device Notification dated August 13, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: This notification is to make you aware of the issue and the importance of completely releasing the tensioning trigger before cutting the implant. Please take the following action: "To ensure your receipt and understanding of this information, Please complete the verification section of this letter and return to Synthes by either of the following methods: " Fax: 1-888-352-9616 or " Scan/email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JDQ

Quantity affected

319

Distribution

Worldwide Distribution - US (nationwide) and country of Mexico.

Date initiated

2013-08-13

Date posted

2013-10-30

Date terminated

2016-08-18

Location

West Chester, PA

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