—#135840

Product

NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K960279
Affected lot / code info: Part #00-5990-036-10; lot 62815809

Why it was recalled

The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

On 4/2/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. All distributors were notified via electronic mail, 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 between 8:00 am and 5:00pm EST.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.

Timeline

Recall initiated: 2015-04-02
Posted by FDA: 2015-05-01
Terminated: 2015-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.