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Terminated

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

FDA Recall Z-0261-2016 · Posted 2015-11-10

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2015-09-08
Date Terminated2017-07-25
Product Quantity201

Reason for Recall

Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

Firm 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.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121308HIP SYSTEMSHowmedica Osteonics Corp. · 2012-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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