Recall Z-0465-2023— Arthrex, Inc.
Class II · Ongoing
Class II FDA medical device recall by Arthrex, Inc., initiated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The devices may be packaged with the wrong reamer size..
- Recalling firm
- Arthrex, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-02
- Firm location
- Naples, FL, United States
Product 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.
Reason for recall
The devices may be packaged with the wrong reamer size.
Data sourced from openFDA. This site is unofficial and independent of the FDA.