Z-0261-2016Class II

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component

Name: Z-0261-2016 Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-09-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-09-08 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component on 2015-09-08. FDA classified it as Class II and gives the reason as "Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0261-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Posted: 2015-11-10
Terminated: 2017-07-25
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker sent an Urgent Medical Device Recall Notifiications dated September 9 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to complete the attached form and return within 5 days by using email [email protected] or FAX 1-888-965-5803. For further questions please call ( 201) 831-5000.
Quantity in commerce: 201
Distribution: Nationwide Distribution
Product codes and lots: Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332 exp- dates july 2019 to august 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0261-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0261-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-10

Product code LPH

K121308Class IIHip SystemsHowmedica Osteonics Corp. / cleared 2012-07-30

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)