Recall Z-2818-2020— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-08-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.. Reason: The products were improperly heat treated..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-03
- Firm location
- Memphis, TN, United States
Product description
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Reason for recall
The products were improperly heat treated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.