PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 21, 2019 Initiated: July 2, 2019 #Z-2233-2019

Product Description

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

Reason for Recall

Cleaning processes potentially being ineffective

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
23
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812. Recalled by Zimmer Biomet, Inc.. Units affected: 23.
Why was this product recalled?
Cleaning processes potentially being ineffective
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2019. Severity: Moderate. Recall number: Z-2233-2019.