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Terminated

Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.

FDA Recall Z-1073-2009 · Posted 2009-03-31

Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeLWJ
Date Initiated2008-10-31
Date Terminated2009-04-14
Product Quantity187 units

Reason for Recall

A possible breach of the sterile barrier packaging (Tyvek pouch).

Firm Action

The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution -- states of NC, 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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