Recall Z-2799-2011 ยท NSQ Restoration, Base Metal
Biomet 3i, LLC
"***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 d
| Date | Jul 13, 2011 (initiated Feb 23, 2010) |
| Status | Terminated |
| Reason | 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 | Error in labeling |
| Action | 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 Affa |
| Quantity | 49 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Europe and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS Implant Innovations, Inc., Apr 25, 1994 |