Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

FDA Recall Z-2079-2008 · Posted 2008-09-16

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-03-17
Date Terminated2008-09-24
Product Quantity1 unit

Reason for Recall

Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

Firm Action

The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005

Root Cause

Process control

Distribution Pattern

The one unit was distributed to an International Stryker branch.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMOsteonics Corp. · 1996-08-14

Official Source

View FDA Recall →

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

↑