Recall Z-1133-2022— Smith & Nephew Orthopaedics GmbH

Name: FDA recall Z-1133-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Orthopaedics GmbH, initiated 2022-04-22. It names one FDA 510(k) clearance: K040212. Product: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right. Reason: Right nails were anodized, marked, and labelled as left nails and vice versa.

Recalling firm: Smith & Nephew Orthopaedics GmbH
Classification: Class II
Status: Ongoing
Initiated: 2022-04-22
Firm location: Tuttlingen, Germany

510(k) clearances named in this recall

1 on FDA's record

K040212 — TRIGEN INTERTANSmith & Nephew, Inc.·cleared 2004-02-20

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

INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

Reason for recall

Right nails were anodized, marked, and labelled as left nails and vice versa

Data sourced from openFDA. This site is unofficial and independent of the FDA.