Z-1916-2024Class II

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw...

Name: Z-1916-2024 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw...
Creator: Synthes (USA) Products LLC
Published: 2024-04-25
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2024-04-25 / Open, Classified / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number... on 2024-04-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1916-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-25
Posted: 2024-05-28
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
Product code: HXX Screwdriver
Reason for recall: 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 tag: manufacturing process
FDA 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- [email protected] 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 in commerce: 261 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI-DI: 10886982075192 Lot Numbers: 97P6250, 97P6251, 97P6252

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1916-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1916-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-28

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)