FDAFDA · Food and drugs·Recall number Z-2232-2019
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Published August 21, 2019 · Recall initiated: July 2, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cleaning processes potentially being ineffective
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
- Lot
- Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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