Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip… recallZ-0572-2008 · Exactech, Inc. · initiated Nov 1, 2007
Terminated All recalls posted in March 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0572-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 1, 2007
- Posted by the FDA
- Mar 12, 2008
- Recalling firm
- Exactech, Inc.
- Quantity
- 10
- Product code
- LPH
- FDA submissions
- K032964
- Distribution
- Distributed to NY, OH and TN.
Product description
Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
Code information (models, lots, serial numbers)
Lot Number: 474042
Other devices under the same FDA submission
1 device cleared under K032964 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 01-001-03-0001Exactech, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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