Recall Z-0978-2015 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Biomet Spine, LLC
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
| Date | Jan 14, 2015 (initiated Aug 22, 2013) |
| Status | Terminated |
| Reason | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft. |
| Root cause | Component design/selection |
| Action | The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com. |
| Quantity | 12 units |
| Distribution | US Distribution to states of: AZ, CA, NY, TN, and TX including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123767 | LANX FUSION SYSTEM- SA Lanx, Inc., Mar 18, 2013 |