—#182996

Product

Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.

FDA product code: GAD — Retractor
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520

Why it was recalled

The products were improperly heat treated.

Root cause (FDA determination)

Process control

Action the firm took

Smith and Nephew issued an Urgent Medical device recall notice. It states the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers in this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2020-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.