Recall Z-1949-2009 ยท EJL Bur, Dental
Biomet Microfixation, Inc.
BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
| Date | Sep 8, 2009 (initiated Feb 16, 2009) |
| Status | Terminated |
| Reason | Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe |
| Root cause | Process control |
| Action | Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425. For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400. |
| Quantity | 79 |
| Distribution | Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.