Recall record at a glance
| Official record | Z-2271-2012 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet 3i, LLC |
| Report date | Sep 5, 2012 |
| Recall initiation date | May 31, 2012 |
| Quantity | 611 units |
| Location | Palm Beach Gardens, FL, United States |
Official product description
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
Why the product was recalled
Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.
Distribution information
Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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