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FDA device recall Z-2838-2011 · posted 2011-07-16 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

On December 1, 2010 Biomet 3i recalled their product Incise Zirconia Coping (CBZR0102). The Coping contains a manufacturing defect. Coping is oversized. All affected direct accounts were notified by letter on December 14, 2010.

Action taken

Biomet 3i sent an "MEDICAL DEVICE RECALL" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product. Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NSP

Quantity affected

16

Distribution

Worldwide Distribution--USA (nationwide) and the country of Canada.

Date initiated

2010-12-01

Date posted

2011-07-16

Date terminated

2011-07-18

Location

Palm Beach Gardens, FL