LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
Recall
- Recall Number
- Z-0810-2010
- Event Number
- 54074
- Firm
- Biomet 3i, LLC
- FEI Number
- 1038806
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 23, 2009
- Posted
- February 22, 2010
- Terminated
- December 15, 2010
- Address
- 4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200
Description
LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.
Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
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