ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
FDA device recall Z-2060-2015 · posted 2015-07-13 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 8
- Distribution
- Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
- Date initiated
- 2015-06-17
- Date posted
- 2015-07-13
- Date terminated
- 2016-03-15
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS (K083497) | Zimmer, Inc. | 2009-02-19 |