—#100612

Product

"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.

FDA product code: NSQ — Restoration, Base Metal
Device class: Class N
Medical specialty: Unknown
510(k) numbers: K934126
Affected lot / code info: Lot number: 6022691.

Why it was recalled

Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.

Root cause (FDA determination)

Error in labeling

Action the firm took

The firm, BIOMET 3i, initially contacted each US customer by telephone using a prepared phone script. Following telephone contact, the firm followed up each call with a faxed "Urgent: Medical Device Recall" letter dated March 1, 2010. International customers were notified first by email then by fax. The letter and email described the product, problem and actions to be taken. The customers were instructed to return the healing abutment(s) for replacement if they have not already opened and used the product; respond with the attached response fax and return the product(s) to the: Regulatory Affairs Department, BIOMET 3i, 4555 Riverside Drive, Palm Beach Gardens, FL 33410, Incident No. IC95863. BIOMET will send a replacement healing abutment(s) once the returned product is received. If you have any questions or concerns, please contact the Recall Coordinator 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 (nationwide) and countries of: Australia, Europe and Japan.

Timeline

Recall initiated: 2010-02-23
Posted by FDA: 2011-07-13
Terminated: 2011-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.