Device product
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Z-2818-2020
Product summary
- Event
- Event 86187
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 111 units
- Official record key
device-enforcement:Z-2818-2020
Official wording
Reason: The products were improperly heat treated.
Code information: Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520
Distribution pattern: 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
Derived failure modes
-
Unknown
The products were improperly heat treated.