Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common
FDA device recall Z-2212-2014 · posted 2014-08-13 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 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,
- Date initiated
- 2014-06-23
- Date posted
- 2014-08-13
- Date terminated
- 2015-07-14
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DORSAL NAIL PLATE, ANATOMICAL (K052248) | Hand Innovations, LLC | 2005-09-14 |
| FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (K041081) | Hand Innovations, Inc. | 2004-07-01 |