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Recall Observatory FDA recall evidence

Device product

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815

Z-2236-2019

July 02, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83314
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-2236-2019

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

    reason.no_named_rule · v1.0.0

    Cleaning processes potentially being ineffective