Home / Recalls / Zimmer Trabecular Metal Technology, Inc. / Z-1325-2015

Z-1325-2015 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
April 1, 2015
Initiation Date
February 4, 2015
Termination Date
July 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

Reason for Recall

One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

Distribution Pattern

US Distribution in the state of CA

Code Information

20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T

Other recalls by Zimmer Trabecular Metal Technology, Inc.

  • Z-1005-2019 Class II — NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Si (February 1, 2019)
  • 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-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-1954-2016 Class II — REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 (April 15, 2016)
  • Z-0851-2015 Class II — NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial (December 2, 2014)