Z-0398-2013Class II

00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head...

Name: Z-0398-2013 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head...
Creator: Zimmer, Inc.
Published: 2010-10-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-10-10 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted... on 2010-10-10. FDA classified it as Class II and gives the reason as "Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0398-2013
Classification: Class II
Status: Terminated
Initiated: 2010-10-10
Posted: 2012-11-19
Terminated: 2014-04-30
Recalling firm: Zimmer GmbH
Product: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
Product code: HWT Template
Reason for recall: Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Zimmer, sent notification by email to consignees beginning October 10, 2012 with a follow-up letter titled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete a spreadsheet of current users and contact information and immediately provide this information via email to: [email protected], and review and become familiar with the content and recommendations of the attached letter sent to the customers. For questions call 1-877-946-2761.
Quantity in commerce: 56,516 all lots, all sizes
Distribution: Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
Product codes and lots: All lots distributed from lot 69998600 (2/20/1996) to present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0389-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0390-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0391-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0392-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0393-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0394-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0395-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0396-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0397-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0398-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0399-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19
Z-0400-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-19

Product code HWT

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)