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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Arthrex, Inc.
- Reason for Recall:
- The devices may be packaged with the wrong reamer size.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 Codes/Lot Numbers:
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Distribution:
Distributed in: AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0465-2023
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