FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: 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.
- Recall number
- Z-0465-2023
- Recalling firm
- Arthrex, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2022-11-02
- Posted
- 2022-12-08
- Terminated
- not on file
- Reason
- The devices may be packaged with the wrong reamer size.
- 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
- 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.
- Lot, serial or model codes
- AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28