Recall Z-0978-2015— Biomet Spine, LLC

Name: FDA recall Z-0978-2015
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Class II · Terminated

Class II FDA medical device recall by Biomet Spine, LLC, initiated 2013-08-22, terminated 2015-03-13. It names one FDA 510(k) clearance: K123767. Product: 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.. 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..

Recalling firm: Biomet Spine, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Terminated: 2015-03-13
Firm location: Broomfield, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K123767 — LANX FUSION SYSTEM- SALanx, Inc.·cleared 2013-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.