Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Recalled by Biomet Spine, LLC Due to The inner diameter of the Sleeve shaft is...

Date: August 22, 2013
Company: Biomet Spine, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomet Spine, LLC directly.

Affected Products

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.

Quantity: 14 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 5 states: AZ, CA, NY, TN, TX

Affected (5 states)Not affected

About Biomet Spine, LLC

Biomet Spine, LLC has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report