Z-0465-2023Class II

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a...

Name: Z-0465-2023 Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a...
Creator: Arthrex, Inc.
Published: 2022-11-02
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2022-11-02 / Open, Classified / root cause: packaging

FDA source

Arthrex, Inc. began a recall of 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 on 2022-11-02. FDA classified it as Class II and gives the reason as "The devices may be packaged with the wrong reamer size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0465-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-02
Posted: 2022-12-08
Recalling firm: Arthrex GmbH
Product: 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.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The devices may be packaged with the wrong reamer size.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The recall notifications were initiated on 11/2/2022 via email. They described the product affected, reason for recall, and provided required actions for the different U.S. and OUS consignees. The U.S. distributor consignees were instructed to contact Field Logistics Services to arrange for return of the affected product. The direct customers (medical facilities) were to contact Arthrex Product Surveillance then they will be further instructed. No response forms were included.
Quantity in commerce: 123 pieces
Distribution: 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.
Product codes and lots: AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-08

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)