Home / Recalls / Zimmer Biomet, Inc. / Z-1033-2018

Z-1033-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
November 29, 2017
Termination Date
April 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,227 in total

Product Description

NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

Reason for Recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.

Code Information

6307-00-008 62125578 6307-00-020 61975784 6307-00-020 62098206 6307-00-030 11004845 6307-00-030 62142198 6307-00-009 62107229 6307-00-021 11004878 6307-00-021 62160819 6307-00-021 62155319 6307-00-021 62162357 6307-00-021 62164084 6307-00-021 62176798 6307-00-021 62174770 6307-00-021 62173770 6307-00-021 62177132 6307-00-021 62172373 6307-00-021 62178184 6307-00-021 62178731 6307-00-021 62183228 6307-00-021 62180483 6307-00-021 62185696 6307-00-021 62181538 6307-00-021 62188142 6307-00-021 11007719 6307-00-021 62189950 6307-00-021 62193587 6307-00-021 62190389 6307-00-021 62192798 6307-00-021 62196210 6307-00-021 62194526 6307-00-021 11007656 6307-00-021 62200791 6307-00-021 62203902 6307-00-021 62206609 6307-00-021 11007666 6307-00-021 62191204 6307-00-021 11007831 6307-00-021 11007677 6307-00-021 11007922 6307-00-021 11007925 6307-00-021 11007944 6307-00-021 62210574 6307-00-021 62208953 6307-00-021 62210107 6307-00-021 62207438 6307-00-021 11008018

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-0362-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)
  • Z-0333-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutr (September 24, 2020)
  • Z-0335-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0328-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0327-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0379-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d (September 24, 2020)
  • Z-0341-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut (September 24, 2020)
  • Z-0385-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)