Smith & Nephew Orthopaedics GmbH

FDA Regulatory Profile

Smith & Nephew Orthopaedics GmbH appears in FDA public data with 2 recalls, 0 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1133-2022, Class II) was initiated on April 22, 2022.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1133-2022Class IIINTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. RightApril 22, 2022
Z-2827-2020Class IIPOLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: July 22, 2020