FDA Device recall Z-2818-2020
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site
- FDA Device
- Class II
- completed
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site by Smith And Nephew, citing the products were improperly heat treated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2818-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-08-03 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | CA, CO, CT, GA, HI, IL, IN, KY, MA, MD, NC, NY, OK, PA, SD, TN, WA, WI |
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.
Identifiers
| code_info | Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2818-2020%22
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