Z-0378-2017Class II

LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular...

Name: Z-0378-2017 LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-08-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-08-29 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem... on 2016-08-29. FDA classified it as Class II and gives the reason as "Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0378-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-11-09
Terminated: 2017-05-02
Recalling firm: Howmedica Osteonics Corp
Product: LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
FDA root cause: Under Investigation by firm
Action: Stryker notified their Branches/Agencies of this recall by e-mail on August 29, 2016 and they were asked to quarantine the affected devices. A Recall Notification Letter and Product Accountability Form was also sent on August 29, 2016 via UPS (with return receipt) to their Branches/Agencies/Hospital Risk Management and Surgeons. On October 11, 2016, Stryker sent an updated recall notification via UPS with return receipt to their affected customers because additional customers and lot numbers were identified.
Quantity in commerce: 42,519 units (total Catalog numbers)
Distribution: US Nationwide and Internationally
Product codes and lots: Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0378-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0378-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code JDI

K022077Class II36Mm V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. / cleared 2002-07-25

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)