FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
- Recall number
- Z-1099-2022
- Recalling firm
- Smith & Nephew Inc
- Product
- LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
- Status
- Terminated
- Initiated
- 2022-04-19
- Posted
- not on file
- Terminated
- 2024-08-16
- Reason
- 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
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 16 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K111711","K112941"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3005551626
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28