FDAClass IIAugust 21, 2019

Orthopedic Salvage System recall

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

Why was Orthopedic Salvage System recalled?

Cleaning processes potentially being ineffective

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.

Product
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Recalling firm
Zimmer Biomet, Inc.
Quantity
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.
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls