Z-1099-2022Class II

LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

Name: Z-1099-2022 LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Creator: Smith & Nephew Inc
Published: 2022-04-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2022-04-19 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 on 2022-04-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1099-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-19
Posted: 2022-05-16
Terminated: 2024-08-16
Recalling firm: Smith & Nephew, Inc.
Product: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-16

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)