—#66433

Product

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

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032964
Affected lot / code info: Lot Number: 474042

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distributed to NY, OH and TN.

Timeline

Recall initiated: 2007-11-01
Posted by FDA: 2008-03-12
Terminated: 2012-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.