Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment
Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Smith & Nephew, Inc. is recalling 111 units of Single RIKKI Retractors, Catalog #7193460. The recall is due to the products being improperly heat treated. These medical devices are used during surgery to hold soft tissue away from the surgical site.
The affected units are distributed across 18 U.S. states, including California, Colorado, Connecticut, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Washington, and Wisconsin. The products were also distributed to six countries: United Arab Emirates, Colombia, Japan, South Korea, Poland, and South Africa.
The specific lot numbers involved in this recall are 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, and 19EM21520. Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers and stop using the affected devices immediately.
The recalled product
- Product
- Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 111
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 18DM14901
- 18FM21215
- 18DM07309
- 18GM20885
- 19EM21519
- 18JM05681
- 19EM21520
Distribution
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