TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of
FDA device recall Z-1246-2023 · posted 2023-03-10 · Open, Classified
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- 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
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
- Date initiated
- 2023-02-01
- Date posted
- 2023-03-10
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548) | Synthes (USA) Products, LLC | 2014-02-28 |