Recall Z-0982-2015 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Biomet Spine, LLC
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
| Date | Jan 15, 2015 (initiated Aug 22, 2013) |
| Status | Terminated |
| Reason | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. |
| Root cause | Component design/selection |
| Action | Distributors and Direct Sales Reps notified via letter to return product. |
| Quantity | 15 |
| Distribution | Distributed in PR and the states of NY, AZ, TN, TX, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123767 | LANX FUSION SYSTEM- SA Lanx, Inc., Mar 18, 2013 |