Z-2235-2019 Class II Terminated
FDA device recall Z-2235-2019 was initiated by Zimmer Biomet, Inc. on Jul 2, 2019 and is designated Class II. Reason for recall: Cleaning processes potentially being ineffective The recall status is terminated (terminated Sep 10, 2021). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2019
- Initiation Date
- Jul 2, 2019
- Termination Date
- Sep 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
Reason for Recall
Cleaning processes potentially being ineffective
Distribution Pattern
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.
Code Information
Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2235-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026