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Terminated

Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653

FDA Recall Z-0572-2008 · Posted 2008-03-12

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-11-01
Date Terminated2012-05-06
Product Quantity10

Reason for Recall

Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm

Firm Action

Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.

Root Cause

Process control

Distribution Pattern

Distributed to NY, OH and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032964EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTSExactech, Inc. · 2003-11-13

Official Source

View FDA Recall →

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

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