Home / Recalls / Zimmer Biomet, Inc. / Z-2183-2018

Z-2183-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
June 20, 2018
Initiation Date
May 11, 2018
Termination Date
November 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
169

Product Description

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Reason for Recall

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.

Code Information

UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290

Other recalls by Zimmer Biomet, Inc.

  • Z-0696-2021 Class II — Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutt (November 20, 2020)
  • Z-0570-2021 Class II — Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacr (November 17, 2020)
  • Z-0396-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap (September 24, 2020)
  • Z-0331-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0356-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu (September 24, 2020)
  • Z-0337-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut (September 24, 2020)
  • Z-0343-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0344-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu (September 24, 2020)
  • Z-0384-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d (September 24, 2020)
  • Z-0370-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)