—#138114

Product

ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083497
Affected lot / code info: Part 47-2492-320-10; lot 62763724

Why it was recalled

A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.

Root cause (FDA determination)

Process control

Action the firm took

On 6/17/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.

Timeline

Recall initiated: 2015-06-17
Posted by FDA: 2015-07-13
Terminated: 2016-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138114. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.