FDA Medical Device Recalls (openFDA)
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 number
- Z-1916-2024
- Recalling firm
- Synthes (USA) Products LLC
- 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
- Status
- Open, Classified
- Initiated
- 2024-04-25
- Posted
- 2024-05-28
- Terminated
- not on file
- Reason
- 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
- Process change control
- Action
- 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.
- Quantity
- 261 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06