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Terminated

Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

FDA Recall Z-0467-03 · Posted 2003-01-28

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeMEH
Date Initiated2002-12-02
Date Terminated2003-08-01
Product Quantity6

Reason for Recall

Product mix-up. 16mm stem in a 18mm package.

Firm Action

Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.

Root Cause

Other

Distribution Pattern

The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944836OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIESOsteonics Corp. · 1995-04-10

Official Source

View FDA Recall →

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

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