Acufex Access Advanced Positioning Kit - indicated for recall
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical…
Why was Acufex Access Advanced Positioning Kit - indicated for recalled?
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 50971615, 50971617 & 50967788
- Product
- Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 271 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
- Recall date
- February 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)