Z-2060-2015Class II

ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device

Name: Z-2060-2015 ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device
Creator: Zimmer, Inc.
Published: 2015-06-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-06-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device on 2015-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2060-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-17
Posted: 2015-07-13
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
Product: ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 8
Distribution: Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
Product codes and lots: Part 47-2492-320-10; lot 62763724

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2060-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2060-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-13

Product code HSB

K083497Class IIZimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. / cleared 2009-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)