Recall Z-2913-2011 ยท LXH Orthopedic Manual Surgical Instrument
Biomet Microfixation, Inc.
"***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Blade used to implant screws.
| Date | Aug 1, 2011 (initiated Mar 15, 2010) |
| Status | Terminated |
| Reason | Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws). |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Biomet Microfixation, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed. If you have any questions |
| Quantity | 35 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.