Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile
FDA device recall Z-2271-2012 · posted 2012-08-24 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- 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.
- Action taken
- Biomet 3i sent a "MEDICAL DEVICE ADVISORY NOTICE" dated May 31, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this recall.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 611 units
- Distribution
- Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
- Date initiated
- 2012-05-31
- Date posted
- 2012-08-24
- Date terminated
- 2013-11-21
- Location
- Palm Beach Gardens, FL
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