FDA-Device2019-08-21Class II

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812

Zimmer Biomet, Inc.
Hazard

Cleaning processes potentially being ineffective

Sold states
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.
Affected count
23
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2233-2019

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