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FDA (Device enforcement)Recalled 2022-04-19closedclass ii

Smith & Nephew Inc: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

Is my product affected?

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

  • UPC 0885558234259
  • UPC 00885556170410

Check against the official notice below — it lists the full affected range.

What happened

Smith & Nephew Inc. is recalling 16 units of orthopedic knee implants due to a labeling error in which JOURNEY II BCS Femoral OXIN LT Size 5 components were packaged in boxes labeled as LEGION NARROW PS OXIN Size 6N RT components. The affected products were distributed worldwide, including in the U.S. states of Connecticut, North Carolina, Colorado, South Carolina, Virginia, Florida, Illinois, and California, as well as Japan. The recalled LEGION NARROW PS OXIN lot number is 21JM17389 (Model 71421276), while the JOURNEY II BCS FEMORAL OXIN mislabeled lot is 21JM18618 (Model 74022125).

The source document does not specify a remedy for consumers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 16 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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