Z-1248-2023Class II

TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and...

Name: Z-1248-2023 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and...
Creator: Synthes (USA) Products LLC
Published: 2023-02-01
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2023-02-01 / Open, Classified / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number... on 2023-02-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1248-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-10
Recalling firm: Synthes (USA) Products LLC
Product: TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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
Root cause tag: labeling and UDI
FDA 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 [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.
Quantity in commerce: 6 units
Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Product codes and lots: UDI-DI: 10886982097262 Lot Number: 610P788

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1248-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1247-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1248-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10

Product code HSB

K131548Class IISynthes Trochanteric Fixation Nail - Advanced SystemSynthes (USA) Products, LLC / cleared 2014-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)