Recalls / —

—#163407

Product

T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

FDA product code

FYA — Gown, Surgical

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K070078

Affected lot / code info

Lot numbers: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, 17113221

Why it was recalled

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Stryker Instruments Div. of Stryker Corporation

Address

4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

Timeline

Recall initiated

2018-02-23

Terminated

2019-05-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #163407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.