FDA Recall Open, Classified

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

Recall: Z-1133-2022 · Initiated April 22, 2022

Recall

Recall Number
Z-1133-2022
Event Number
90118
Firm
Smith & Nephew Orthopaedics GmbH Alemannenstr. 14 Tuttlingen Germany
FEI Number
3002465897
Product Code
JDS
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
April 22, 2022

Description

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

Action

The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.

Distribution

Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.

Quantity

17 units