Synthes (USA) Products LLC 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Synthes (USA) Products LLC
Lot Codes / Batch Numbers
UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Products Sold
UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
Synthes (USA) Products LLC is recalling STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing o due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026