Stryker recalls Harmonic ACE +7 Shears with Advanced Hemostasis due to distribution without regulatory clearance. Affected units include specific model and lot numbers. Consumers should contact Stryker for details.
Product was distributed without receiving regulatory clearance.
Stryker is recalling Harmonic ACE +7 Shears with Advanced Hemostasis that were distributed without receiving regulatory clearance. This means the product may not be safe for medical use as it was not approved by the relevant authorities.
The product was distributed without receiving regulatory clearance, meaning it was not approved by the relevant medical authorities. This could lead to potential safety issues during surgical procedures if the device does not meet the required safety standards.
Medical professionals using the Stryker Harmonic ACE +7 Shears with Advanced Hemostasis for surgical procedures are likely affected. Patients undergoing surgery with these instruments could be at risk if the device was used without proper regulatory approval.
Check for the model number HARH36 and lot number 12444050 on the product. The product was sold with a specific catalog number and GTIN.
Reach out to Stryker Sustainability Solutions for specific instructions on how to handle the recalled product.
The product was distributed without receiving regulatory clearance, which means it was not approved by the relevant medical authorities.
Contact Stryker Sustainability Solutions for specific instructions on how to handle the recalled product.
Yes, the model number is HARH36 and the lot number is 12444050.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1327-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1327-2021 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.
