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Open, Classified

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

FDA Recall Z-1133-2022 · Posted None

Recalling FirmSmith & Nephew Orthopaedics GmbH
Recall StatusOpen, Classified
Product CodeJDS
Date Initiated2022-04-22
Product Quantity17 units

Reason for Recall

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

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040212TRIGEN INTERTANSmith & Nephew, Inc. · 2004-02-20

Official Source

View FDA Recall →

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

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