Z-1241-2015Class II

LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a...

Name: Z-1241-2015 LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-02-03
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-02-03 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a... on 2015-02-03. FDA classified it as Class II and gives the reason as "Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1241-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Posted: 2015-03-03
Terminated: 2017-04-07
Recalling firm: Howmedica Osteonics Corp
Product: LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
FDA root cause: Under Investigation by firm
Action: Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.
Quantity in commerce: 9 units
Distribution: Distributed in the states of GA, MA, NC, NY & PA.
Product codes and lots: Lot Code 48681201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1241-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-03

Product code JDI

K010757Class IILfit V40 Femoral Head ComponentsHowmedica Osteonics Corp. / cleared 2001-04-11

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)