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Terminated

Reliance PF Femoral Stem

FDA Recall Z-0108-06 · Posted 2005-11-01

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMAY
Date Initiated2005-08-24
Date Terminated2006-04-05
Product Quantity8487 units

Reason for Recall

The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

Firm Action

A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.

Root Cause

Other

Distribution Pattern

nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970200RELIANCE PF FEMORAL STEMSHowmedica Corp. · 1997-04-09

Official Source

View FDA Recall →

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

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