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

Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical

FDA Recall Z-0799-2011 · Posted 2010-12-22

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeKWS
Date Initiated2010-11-05
Date Terminated2011-04-05
Product Quantity34 units

Reason for Recall

Complaints of fracturing were reported for affected trial products.

Firm Action

Encore Medical notified consignees by letter on 11/5/2010.

Root Cause

Device Design

Distribution Pattern

TX, FL, SC, GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080402ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38Encore Medical L.P. · 2008-03-28

Official Source

View FDA Recall →

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

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