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Recall Observatory FDA recall evidence

Device product

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

Z-1099-2022

April 19, 2022

Class II

Product summary

Firm
Smith & Nephew Inc
Event
Event 90078
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-1099-2022

Official wording

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.

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

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.