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.
Recall
- Recall Number
- Z-0983-2015
- Event Number
- 70070
- Firm
- Biomet Spine, LLC
- FEI Number
- 3012447612
- Product Code
- OVD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 22, 2013
- Posted
- January 15, 2015
- Terminated
- March 13, 2015
- Address
- 310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464
Description
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.
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.
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: [email protected] if you have any questions regarding this recall.
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
14 units