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Terminated

Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads.

FDA Recall Z-0556-2010 · Posted 2009-12-22

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2009-01-14
Date Terminated2012-07-18
Product Quantity786 total stems

Reason for Recall

Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

Firm Action

Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.

Root Cause

Device Design

Distribution Pattern

Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020615SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMSHowmedica Osteonics Corp. · 2002-05-13

Official Source

View FDA Recall →

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

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