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Open, Classified

TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S

FDA Recall Z-1247-2023 · Posted 2023-03-10

Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2023-02-01
Product Quantity5 units

Reason for Recall

TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

Firm Action

DePuy Synthes issued Urgent Medical Device Recall (Removal) on 2/1/23 to US accounts. Canada and Japan and the affiliates in-country executing the recall per their local regulations. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have the subject products and quarantinethem immediately. 2.Contact your DePuy Synthes Sales Consultant or customer support services at [email protected] to coordinate the return/credit of the subject products. 3.Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) [email protected] within three (3) business days of receipt of this notification. Pleaseinclude in the email subject: FA 2219469 TFNA Incorrect Sized Nail 4.Please complete the attached Business Response Form even if you do not have the subject products onhand. 5.Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage,transport, store, stock, or use the subject products). 6.If any of the subject products have been forwarded to another facility, contact that facility and providethem with this notice. 7.Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information requests, please visit our website: https://www.jnjmedicaldevices.com/mir.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.

Official Source

View FDA Recall →

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

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