Z-0572-2008

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

Name: Z-0572-2008 Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL...
Creator: Exactech, Inc.
Published: 2007-11-01
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2007-11-01 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653 on 2007-11-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0572-2008
Status: Terminated
Initiated: 2007-11-01
Posted: 2008-03-12
Terminated: 2012-05-06
Recalling firm: Exactech, Inc.
Product: Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 10
Distribution: Distributed to NY, OH and TN.
Product codes and lots: Lot Number: 474042

Product code LPH

K032964Class IIExactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsExactech, Inc. / cleared 2003-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)