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Terminated

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

FDA Recall Z-1099-2022 · Posted None

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2022-04-19
Date Terminated2024-08-16
Product Quantity16 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112941LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTSSmith & Nephew, Inc. · 2011-12-20K111711JOURNEY II BCS KNEE SYSTEMSmith & Nephew, Inc. · 2011-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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