—#129004

Product

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K072642
Affected lot / code info: Model Number IEHA458, Lot number: 1167545.

Why it was recalled

Identifiers on the label are correct but the label has the incorrect color coding.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to NH and TX.

Timeline

Recall initiated: 2014-06-25
Posted by FDA: 2014-09-05
Terminated: 2014-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129004. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.