Recall Z-2212-2014 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
| Date | Aug 13, 2014 (initiated Jun 23, 2014) |
| Status | Terminated |
| Reason | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck. |
| Root cause | Nonconforming Material/Component |
| Action | On June 23, 2014 Biomet issued recall notification to their consignees via letter. Notification included affected product issue and instructions for return were provided. Distributors who had affected hospitals in their regions were notified and provided with a copy of the notice that was sent to the hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. A response form was provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis. |
| Quantity | 37 |
| Distribution | The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina, |
| FDA record | Open on fda.gov |