Home / Recalls / Zimmer Trabecular Metal Technology, Inc. / Z-1892-2017

Z-1892-2017 Class III Terminated

Recalled by Zimmer Trabecular Metal Technology, Inc. — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
July 7, 2016
Termination Date
May 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
299 units; 200 brochures

Product Description

The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

Reason for Recall

This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.

Distribution Pattern

Nationwide Distribution

Other recalls by Zimmer Trabecular Metal Technology, Inc.

  • Z-1006-2019 Class II — NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Si (February 1, 2019)
  • Z-1005-2019 Class II — NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Si (February 1, 2019)
  • Z-1954-2016 Class II — REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 (April 15, 2016)
  • Z-1951-2016 Class II — TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886043 (April 15, 2016)
  • Z-1955-2016 Class II — 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MM (April 15, 2016)
  • Z-1950-2016 Class II — POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058780 (April 15, 2016)
  • Z-1952-2016 Class II — TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886053 (April 15, 2016)
  • Z-1953-2016 Class II — TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606 (April 15, 2016)
  • Z-1325-2015 Class II — NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D (February 4, 2015)
  • Z-0851-2015 Class II — NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial (December 2, 2014)