—#87441

Product

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.

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K012911
Affected lot / code info: Lot 877423

Why it was recalled

Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.

Timeline

Recall initiated: 2009-11-23
Posted by FDA: 2010-02-22
Terminated: 2010-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87441. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.