Recall Z-2271-2012— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2012-05-31, terminated 2013-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-31
- Terminated
- 2013-11-21
- Firm location
- Palm Beach Gardens, FL, United States
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.