Class 2 Device Recall Stryker Toga

• Date Initiated by Firm: February 23, 2018
• Create Date: April 24, 2018
• Recall Status: Terminated on May 23, 2019
• Recall Number: Z-1500-2018
• Recall Event ID: 79779
• 510(K)Number: K070078
• Product Classification: surgical gown - Product Code FYA
• Product: T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
• Code Information: 17071877
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E Milham Ave; Portage MI 49002-9704
• For Additional Information Contact: Kara Spath; 269-323-7700
• Manufacturer Reason for Recall: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments at 866-521-2762, or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification; 4) If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF; 5) If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you and should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Customer with questions or concerns may call (800)253-3210.
• Quantity in Commerce: 34,570 total products
• Distribution: US Nationwide and Ireland, Japan, South Korea, UK
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FYA