—#199336

Product

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

FDA product code: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K190085
Affected lot / code info: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

Why it was recalled

A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.

Timeline

Recall initiated: 2023-03-27
Posted by FDA: 2023-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.