Recall Z-0983-2015 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Biomet Spine, LLC
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.
| Date | Jan 15, 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. |
| Root cause | Device Design |
| Action | The firm, Lanx, sent a letter to their Consignees/customers dated October 15, 2013. The letter describes the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with conforming product. Please contact Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com if you have any questions regarding this recall. |
| Quantity | 14 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 |