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
Synthes is recalling certain Stardrive screwdrivers that lack a 5-degree relief cut around the tip. This design flaw means they might not properly engage with specific surgical screws, potentially delaying surgery.
The screwdrivers lack a 5-degree relief cut around the tip, which is necessary for proper engagement with 1.3mm and 1.5mm surgical screws. Without this feature, the screwdrivers may not securely hold the screws, leading to potential surgical delays.
Orthopedic surgeons and medical staff using the recalled screwdrivers during surgery. Patients at risk if the screwdrivers cause surgical delays.
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.
Identify the lot number on the screwdriver packaging or label to determine if it is affected (97P6250, 97P6251, or 97P6252).
The screwdrivers lack a 5-degree relief cut around the tip, which may prevent proper engagement with 1.3mm and 1.5mm surgical screws, potentially causing surgical delays.
Check the lot number on the screwdriver to see if it is affected (97P6250, 97P6251, or 97P6252). If it is, contact Synthes for further instructions.
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.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1916-2024 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1916-2024 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
