Z-1099-2022 Class II Terminated
FDA device recall Z-1099-2022 was initiated by Smith & Nephew Inc on Apr 19, 2022 and is designated Class II. 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. The recall status is terminated (terminated Aug 16, 2024). Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Apr 19, 2022
- Termination Date
- Aug 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
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 Pattern
Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1099-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026