Home / Recalls / Zimmer Biomet, Inc. / Z-0721-2018

Z-0721-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-0721-2018 was initiated by Zimmer Biomet, Inc. on August 1, 2017 and is designated Class II. Reason for recall: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier. The recall status is terminated (terminated March 18, 2020). Affected quantity: 3,350 units total.

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
August 1, 2017
Termination Date
March 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,350 units total

Product Description

Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

Reason for Recall

The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

Distribution Pattern

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.

Code Information

a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026); b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026); c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026); d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)

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-0385-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (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-0325-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0367-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 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)
  • Z-0330-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0340-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neut (September 24, 2020)
  • Z-0386-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)

FDA data resources