Recall Z-2060-2015
Zimmer, Inc. · initiated June 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Codes / lots: Part 47-2492-320-10; lot 62763724
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2060-2015
- Initiated
- June 17, 2015
- Posted by FDA
- July 13, 2015
- Terminated
- March 15, 2016
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 8
- Distribution
- Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
- Recalling firm
- Zimmer, Inc., Warsaw, IN