Home / Recalls / Biomet Spine, LLC / Z-0978-2015

Z-0978-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
January 21, 2015
Initiation Date
August 22, 2013
Termination Date
March 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

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.

Distribution Pattern

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

Code Information

Model 8630-0204 Lots TU00052, TU00052A, and TU00117

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  • Z-2744-2015 Class II — Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervic (August 5, 2015)
  • Z-2759-2015 Class II — Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model (July 22, 2015)
  • Z-1466-2015 Class II — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage (March 12, 2015)
  • Z-2152-2015 Class II — Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial S (March 12, 2015)
  • Z-1465-2015 Class II — Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: (March 12, 2015)
  • Z-0982-2015 Class II — Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630- (August 22, 2013)
  • Z-0983-2015 Class II — Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timbe (August 22, 2013)
  • Z-1146-2015 Class II — Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy se (November 30, 2012)