Z-2235-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- July 2, 2019
- Termination Date
- September 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.