Stryker recalls Farabeuf Clamp for 3.5mm Screws PRO (Catalog # 705463) due to laser etching on the wrong side of the lever arm. This could cause incorrect mode detection during use.
Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
Stryker is recalling Farabeuf Clamps for 3.5mm Screws PRO (Catalog # 705463) because laser etching indicating compression or distraction mode is on the wrong side of the lever arm. This could lead to incorrect mode detection during use, potentially causing improper surgical adjustments.
The laser etching that shows if the device is in compression or distraction mode is on the wrong side of the lever arm. This could cause the user to misinterpret the device's current mode, leading to improper surgical adjustments. However, the hazard does not involve immediate physical harm or failure in normal use.
Surgical professionals using the Farabeuf Clamp for 3.5mm Screws PRO (Catalog # 705463) are most at risk. This recall affects specific surgical tools used in orthopedic procedures.
Check for the product name 'Farabeuf Clamp for 3.5mm Screws PRO' and catalog number 705463. The recall applies to specific surgical tools sold with lot number 04857V.
Verify the catalog number 705463 and lot number 04857V on the device.
The recall indicates a potential for incorrect mode detection during use, but the hazard does not involve immediate physical harm or failure in normal use. This is considered low risk.
Check for the product name 'Farabeuf Clamp for 3.5mm Screws PRO' and catalog number 705463. The recall applies to specific surgical tools sold with lot number 04857V.
The recall does not specify a remedy, so you should check with Stryker directly for further instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2244-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2244-2018 from Stryker. 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.
