LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
This recall has been terminated (originally issued April 19, 2022).
- Company
- Smith & Nephew Inc
- Recall Initiated
- April 19, 2022
- Terminated
- August 16, 2024
- Recall Number
- Z-1099-2022
- Quantity
- 16 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
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
Root Cause
Nonconforming Material/Component
Action Taken
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.