Lower riskMedical device recall · FDA · Published April 25, 2024
Synthes Stardrive Screwdrivers May Cause Surgical Delay - Recall
Synthes recalls Stardrive screwdrivers without a 5-degree relief cut that may not engage with 1.3mm/1.5mm screws, causing surgical delays. Affected units include specific lot numbers for orthopedic surgery tools.
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
Take action
Contact the company
📍Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
“Synthes Stardrive Screwdrivers May Cause Surgical Delay - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55304-synthes-stardrive-screwdrivers-may-cause-surgical-delay-recall. Based on FDA recall #Z-1916-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2024%22&limit=1).
Synthes (USA) Products LLC recalled STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC screwdrivers because they may not engage with screws, potentially causing surgical delays. The Food and Drug Administration announced the Class II recall on April 25, 2024.
The Stardrive Screwdrivers were manufactured without a 5-degree relief cut around the tip. This defect means they will not engage with their respective 1.3mm and 1.5mm screws, which may result in surgical delay.
Context
GovInfoNow's records show Synthes (USA) Products LLC has 19 other recalls on record since July 21, 2017. Other recent recalls of similar products include the Synthes RIA Tube Assembly Recall (Jan. 24, 2024), the Tornier Perip Screw Recall (Dec. 19, 2025), and the Medicrea IB3D PL Instruments Set Recall (Oct. 29, 2025).
How to tell if you have this one
Look for the product name 'STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC' with lot numbers 97P6250, 97P6251, or 97P6252. These screwdrivers are intended for orthopedic surgery.
Brand
Synthes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Identify the lot number on the screwdriver packaging or label to determine if it is affected (97P6250, 97P6251, or 97P6252).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Are there any safety risks if I use the recalled screwdriver?
The recall indicates a risk of surgical delays, but the screwdrivers do not cause immediate injury or death. This is a low-risk issue for surgical procedures.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1916-2024 (April 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1916-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.