FDA recall Z-2818-2020

Smith & Nephew, Inc. · Class II · device

Product

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.

Distribution

US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA

Key facts

Status
Ongoing
Initiation date
2020-08-03
Report date
2020-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2818-2020