E of this notification is to advise you that Stryker Instruments is voluntarily recalling select disposable products that were distributed between October 16, 2017 and November 14, 2017. Please refer to the specific product numbers and descriptions listed in the attached table below. Product # 0206-512-000 Product Description Break-Away Femoral Nozzle Lot Number(s) 17279012 0206-530-000 180-Gram Cement Cartridge with Breakaway Femoral Nozzle 17277012, 17283012 0206-546-000 Femoral Canal P.
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How to fill out the Stryker Urgent Medical Device Recall Notification online
This guide provides clear, step-by-step instructions on how to fill out the Stryker Urgent Medical Device Recall Notification form online. It aims to support users in accurately completing the form to ensure compliance with the voluntary recall process.
Follow the steps to fill out the form accurately.
- Press the ‘Get Form’ button to access the Stryker Urgent Medical Device Recall Notification form and open it in the document editor.
- Carefully read the Recall Notification section to understand the purpose and details of the recall before proceeding.
- In the Business Reply Form sections labeled 'Product Number(s)' and 'Lot Number(s)', input the respective details for any affected products found in your inventory.
- Indicate the 'Quantity on Hand (each)' for each affected product to ensure accurate reporting of stock.
- Complete the sections labeled 'Account Name', 'Account #', 'Print Customer Name', 'Customer Title', 'Contact Phone Number', and 'Email Address' to provide your facility's contact information.
- Sign and date the form at the indicated areas to confirm receipt and understanding of the notification.
- If applicable, provide details of any further distribution of the affected products in the designated section, including the name and address of the recipient.
- Once all sections are completed, save your changes and prepare to return the form via fax at 866-521-2762 or email to erin.bissonnette@stryker.com.
Complete your documents online today to ensure compliance with the recall process.
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Who sends out recall notices?
Manufacturers will notify registered owners by first class mail within 60 days of notifying NHTSA of a recall decision. Manufacturers should offer a proper remedy to the owner.
Are there any recalls on Stryker?
RECALLED STRYKER HIP IMPLANT SYSTEMS All Rejuvenate and ABG II made by Stryker have been either recalled through the FDA or recalled voluntarily by the company.
What is a recall notice in medical terms?
Recall means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.
What happens when a medical device is recalled?
Actions Taken for Medical Device Recalls There are several types of actions that may be taken during a recall, including inspecting the device for problems, repairing the device, adjusting settings, re-labeling, destroying the device, notifying patients of a problem, and monitoring patients for health issues.
What is a recall notification?
Recall notifications call the consumer's attention to products that need to be repaired, modified or replaced after the manufacturing process. Many times, a simple replacement part may be necessary to improve performance of the product.
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