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Terminated

Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.

FDA Recall Z-0086-2010 · Posted 2009-10-28

Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeKWY
Date Initiated2009-04-29
Date Terminated2010-05-25
Product Quantity23

Reason for Recall

A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.

Firm Action

Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.

Root Cause

Device Design

Distribution Pattern

AZ, CA, FL, MA, MI. No military, government or foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050966PIVOT BIPOLAR FEMORAL HEADOrtho Development Corp. · 2005-07-07

Official Source

View FDA Recall →

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

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