Recall Z-0635-2022— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104. Reason: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process.
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-14
- Firm location
- Memphis, TN, United States
Product description
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Reason for recall
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Data sourced from openFDA. This site is unofficial and independent of the FDA.