CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report

Orthopedic Salvage System (OSS) Hybrid Poly Tibia recalled

Zimmer Biomet is recalling Orthopedic Salvage System (OSS) Hybrid Poly Tibia, distributed in 18 states. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled19

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2236-2019
FDA event ID: 83314
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2019
FDA classified: 9 Aug 2019
Reported: 21 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

2 Jul 2019	Recall initiated by company
9 Aug 2019	Classified by FDA	+38 days
21 Aug 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cleaning processes potentially being ineffective

Product as listed by the FDA

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

Where it was distributed

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.

Arizona California District of Columbia Georgia Illinois Kentucky Louisiana Massachusetts Maryland Minnesota North Carolina New Jersey New Mexico Ohio Oklahoma Oregon South Carolina Texas

Questions about this recall

Is Orthopedic Salvage System (OSS) Hybrid Poly Tibia recalled?

Yes. Zimmer Biomet recalled Orthopedic Salvage System (OSS) Hybrid Poly Tibia on 2 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2236-2019.

Why was it recalled?

Cleaning processes potentially being ineffective

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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