Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaed...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1676-2013.
The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1676-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1676-2013.
Zimmer, Inc.
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Zimmer, Inc. Recall FAQ
Zimmer, Inc. is the subject of a medical devices safety report: Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaed.... The notice was published on June 11, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.