Device product
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Z-2233-2019
Product summary
- Event
- Event 83314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-2233-2019
Official wording
Reason: Cleaning processes potentially being ineffective
Code information: Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.
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.
Derived failure modes
-
Unknown
Cleaning processes potentially being ineffective