FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
- Recall number
- Z-2060-2015
- Recalling firm
- Zimmer, Inc.
- Product
- ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
- Status
- Terminated
- Initiated
- 2015-06-17
- Posted
- 2015-07-13
- Terminated
- 2016-03-15
- 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 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.
- Quantity
- 8
- Distribution
- Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
- Lot, serial or model codes
- Part 47-2492-320-10; lot 62763724
- 510(k) numbers
- ["K083497"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28