FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
- Recall number
- Z-1246-2023
- Recalling firm
- Synthes (USA) Products LLC
- Product
- TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2023-03-10
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by 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 ra-dpyus-csspecial@its.jnj.com 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) toOneMD-Field-Actions@its.jnj.com 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.
- Quantity
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
- Lot, serial or model codes
- UDI-DI 10886982097033 Lot Number: 607P512
- 510(k) numbers
- ["K131548"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28