Z-0317-2017Class II

Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece

Name: Z-0317-2017 Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Creator: Zimmer Biomet, Inc.
Published: 2016-09-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-09-28 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece on 2016-09-28. FDA classified it as Class II and gives the reason as "Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0317-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-28
Posted: 2016-10-26
Terminated: 2020-04-16
Recalling firm: Zimmer GmbH
Product: Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Product code: HAB Saw, Powered, And Accessories
Reason for recall: Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 9/28/2016, URGENT MEDICAL DEVICE FIELD REMOVAL notifications were sent to the affected distributors and Risk Managers / Surgeons 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. Risk Managers and Surgeons Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with quarantining all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility for the initial preventative maintenance and arrange for a loaner device. It is estimated that your handpieces will undergo preventative maintenance sometime between November 2016 and March 2017. 4. Complete Attachment 3 Certificate of Acknowledgement. a. Return a digital copy via email to [email protected] or via fax to 574-372-1683 within three (3) days. b. Retain a copy of the Acknowledgement Form with your field removal records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field removal that are recommended beyond your existing follow up schedule. 3. Complete Attachment 3 Certificate of Acknowledgement. a. Return a digital copy via email to
Quantity in commerce: 703
Distribution: Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Product codes and lots: Item Number 00-5927-040-00 Serial Number All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0317-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0317-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-26

Product code HAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)