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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm May 12, 2021
Create Date August 06, 2021
Recall Status1 Open3, Classified
Recall Number Z-2211-2021
Recall Event ID 88199
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
Product Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Code Information Serial Numbers:  111427102713678 UDI:N/A
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Victoria Haney
269-389-8306
Manufacturer Reason
for Recall		 Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021. Letter states reason for recall, health risk and action to take: Customers are instructed to: 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax (269) 488-8691or email productfieldaction@stryker.com to Stryker's Regulatory Department. 1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number). 2. If you are using the product in a home, Stryker recommends that you discontinue use of the product. 3. Complete and sign the enclosed business reply form. a. Return this signed letter by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers Regulatory Department. 4. Upon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable. If you have any questions or concerns, contact us at +1 269 389 8306 or productfieldaction@stryker.com. We apologize for any disruption this may cause.
Quantity in Commerce 1 unit
Distribution Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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