Recall Z-1947-2009 ยท DZA Drill, Dental, Intraoral
Biomet 3i, LLC
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.
| Date | Sep 1, 2009 (initiated Jun 29, 2009) |
| Status | Terminated |
| Reason | Some of the packages of ACT3020, drills may actually contain an ACT3220 drill. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were notified of recall by telephone and by faxed an Urgent: Medical Device Recall letter, dated June 30, 2009. The letter stated the problem. The letter also asked customers to check their surgical kits and confirm the drill is placed in the correct space within the kit. Customers are to verify that the shank of the drill is marked as ACT3020 on one side and as 3.0 x 20mm on the opposite side. The letter also stated the clinical implications. Customers are to respond with the attached response fax and then return the drills to BIOMET 3i. Once the returned product is received, |
| Quantity | 29 units |
| Distribution | Worldwide Distribution -- Korea, Netherlands, Taiwan, United Kingdom, and USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.