Recall Z-1099-2022— Smith & Nephew Inc
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew Inc, initiated 2022-04-19, terminated 2024-08-16. It names 2 FDA 510(k) clearances: K112941, K111711. Product: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5. 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..
- Recalling firm
- Smith & Nephew Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-19
- Terminated
- 2024-08-16
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
2 on FDA's record- K112941 — LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
- K111711 — JOURNEY II BCS KNEE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.