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Terminated

Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439

FDA Recall Z-0664-2009 · Posted 2009-01-28

Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeLWJ
Date Initiated2008-10-07
Date Terminated2009-04-01
Product Quantity6 units

Reason for Recall

Sterility may be compromised due to breach in packaging.

Firm Action

On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.

Root Cause

Package design/selection

Distribution Pattern

USA distribution to dealers in TX and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953268DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENTStelkast Company · 1996-01-17

Official Source

View FDA Recall →

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

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