—#207547

Product

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010

FDA product code: HXX — Screwdriver
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252

Why it was recalled

Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay

Root cause (FDA determination)

Process change control

Action the firm took

DePuy Synthes issued Urgent Medical Device Recall (Removal) Letter on 4/26/24. Letter states reason for recall, health risk and action to take: Examine your inventory to determine if you have the subject product lots and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at ra-dpyuscsspecial@ its.jnj.com to coordinate the return/credits of the subject product lots. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMDField- Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include in the email subject: FA 2363331. 4. Please complete the attached Business Response Form even if you do not have the subject product lots 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 product lots 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 country of Canada.

Timeline

Recall initiated: 2024-04-25
Posted by FDA: 2024-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.