Home / Recalls / Zimmer Trabecular Metal Technology, Inc. / Z-0851-2015

Z-0851-2015 Class II Terminated

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

FDA device recall Z-0851-2015 was initiated by Zimmer Trabecular Metal Technology, Inc. on December 2, 2014 and is designated Class II. Reason for recall: During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. The recall status is terminated (terminated August 28, 2015). Affected quantity: 8 units.

Recall Details

Product Type
Devices
Report Date
December 31, 2014
Initiation Date
December 2, 2014
Termination Date
August 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units

Product Description

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

Reason for Recall

During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.

Distribution Pattern

Worldwide Distribution - US Distribution and the countries of Australia and Denmark.

Code Information

Part number 00-5887-045-00 Lot number 62592928

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-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-1955-2016 Class II — 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MM (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-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-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-1325-2015 Class II — NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D (February 4, 2015)

FDA data resources