CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Small Joint OATS Set recalled by Arthrex
Arthrex is recalling Small Joint OATS Set, distributed in 20 states. The recall was initiated on 2 Nov 2022 and the FDA has classified it as Class II.
Check your package
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-0465-2023
- FDA event ID
- 91143
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2022
- FDA classified
- 8 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 2 Nov 2022 | Recall initiated by company | |
| 8 Dec 2022 | Classified by FDA | +36 days |
| 14 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices may be packaged with the wrong reamer size.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Where it was distributed
Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
AlabamaArkansasCaliforniaColoradoFloridaIowaIllinoisLouisianaMassachusettsMarylandMichiganNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTexasUtahVirginia
Questions about this recall
Is Small Joint OATS Set recalled?
Yes. Arthrex recalled Small Joint OATS Set on 2 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0465-2023.
Why was it recalled?
The devices may be packaged with the wrong reamer size.
Which lots are affected?
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Where was it sold?
Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
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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