Recall Z-2060-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer, Inc.
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
| Date | Jul 13, 2015 (initiated Jun 17, 2015) |
| Status | Terminated |
| Reason | 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 | Process control |
| Action | 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 concer |
| Quantity | 8 |
| Distribution | Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083497 | ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS Zimmer, Inc., Feb 19, 2009 |