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Terminated

Distal Centralizer 10 mm

FDA Recall Z-0315-2011 · Posted 2010-11-03

Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeKWY
Date Initiated2010-07-28
Date Terminated2010-11-04
Product Quantity39 units

Reason for Recall

The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.

Firm Action

Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962448PRIMALOC CEMENTED HIP SYSTEMOrtho Development Corp. · 1996-09-19

Official Source

View FDA Recall →

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

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