Z-2482-2012Class II

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

Name: Z-2482-2012 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head...
Creator: Zimmer, Inc.
Published: 2011-04-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-04-01 / 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 2011-04-01. FDA classified it as Class II and gives the reason as "Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose...". 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-2482-2012
Classification: Class II
Status: Terminated
Initiated: 2011-04-01
Posted: 2012-09-28
Terminated: 2014-05-16
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: Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580. For questions regarding this recall call 574-372-4753.
Quantity in commerce: 231,641
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
Product codes and lots: All lots including lot 78939000 (1/7/2002) to present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2482-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2473-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2474-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2475-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2476-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2477-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2478-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2479-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2480-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2481-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2482-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2483-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28
Z-2484-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

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)