Home / Recalls / Zimmer Trabecular Metal Technology, Inc. / Z-1005-2019

Z-1005-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 20, 2019
Initiation Date
February 1, 2019
Termination Date
May 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units

Product Description

NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

Reason for Recall

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Distribution Pattern

Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS

Code Information

Lot Numbers: 63253751 63257915 63291542 UDI: (01) 00889024307858 (17) 210228 (10) 63253751 (01) 00889024307858 (17) 210228 (10) 63257915 (01) 00889024307858 (17) 210430 (10) 63291542

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-1892-2017 Class III — The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device (July 7, 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-1950-2016 Class II — POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058780 (April 15, 2016)
  • 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-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-1955-2016 Class II — 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MM (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)