Recalls / —
—#193328
Product
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K111711, K112941
- Affected lot / code info
- LEGION NARROW PS OXIN SZ 6N RT: Model Number: 71421276; Lot: 21JM17389; UDI: (01)0885558234259(17)310925(10)21JM17389 JRNY II BCS FEMORAL OXIN LT SZ 5: Model Number: 74022125; Lot: 21JM18618; UDI: (01)00885556170410(17)310926(10)21JM18618
Why it was recalled
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Initial consignees were notified via email and overnight mail on 04/19/2022. The consignees were instructed to inspect their inventory, return affected product, and complete the response form.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 6409 E Holmes Rd, Memphis, Tennessee 38141-8310
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
Timeline
- Recall initiated
- 2022-04-19
- Terminated
- 2024-08-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #193328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.