Recall Z-0321-2011 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.
| Date | Nov 4, 2010 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | Healing abutment may not fully seat on the implant. |
| Root cause | Other |
| Action | Consignees were notified by an Urgent: Medical Device Recall letter on 09/07/2010. The letter identified the affected product and gave some background regarding the issue. It also stated the possible impact and the cases that were not affected. Consignees were instructed to contact BioHorizons Returns & Complaints Manager Rick Self at 205-986-1250, if they have unused product from the affected lot, for a Return Authorization Number and to receive replacements. The attached Notification Certification form is to be completed and returned via fax. |
| Quantity | 396 |
| Distribution | Worldwide Distribution -- USA, including PA, MI, NY, AL, WA, and WV, and countries of Canada and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT BioHorizons Implant Systems, Inc., Dec 2, 2005 |