Home / Recalls / Biomet Spine, LLC / Z-1146-2015

Z-1146-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

FDA device recall Z-1146-2015 was initiated by Biomet Spine, LLC on November 30, 2012 and is designated Class II. Reason for recall: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification The recall status is terminated (terminated May 22, 2015). Affected quantity: 1999.

Recall Details

Product Type
Devices
Report Date
March 4, 2015
Initiation Date
November 30, 2012
Termination Date
May 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1999

Product Description

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Reason for Recall

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.

Code Information

LOT Numbers: L561968 and L570545 Product Code: 77031600

Other recalls by Biomet Spine, LLC

  • Z-1253-2016 Class II — 10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model (February 12, 2016)
  • Z-0203-2016 Class II — MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate Sy (September 29, 2015)
  • 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-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-1466-2015 Class II — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage (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-0978-2015 Class II — Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Mode (August 22, 2013)

FDA data resources