—#121173

Product

Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

FDA product code: JDQ — Cerclage, Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110789
Affected lot / code info: Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078

Why it was recalled

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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

Timeline

Recall initiated: 2013-08-13
Posted by FDA: 2013-10-30
Terminated: 2016-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121173. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.