Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-0983-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: August 22, 2013

Date Posted: January 21, 2015

Recall Number: Z-0983-2015

Event ID: 70070

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205

Distribution Pattern:

US Distribution to states of: AZ, CA, NY, TN and TX including PR.

Voluntary or Mandated:

Voluntary: Firm initiated