—#205918

Product

TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K131548, K160167
Affected lot / code info: UDI: 10886982096562 Lot Number: 4489P98

Why it was recalled

Products not sterilized, sterility cannot be confirmed

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include in the email subject: FA 2348044. 4. Please complete the attached Business Response Form even if you do not have the subject products on hand. 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 provide them 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 request, please visit our website: https://www.jnjmedicaldevices.com/mir

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

Timeline

Recall initiated: 2024-01-24
Posted by FDA: 2024-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.