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NeXus I, II and III Rollators - Association with falls and serious injury - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Dana Douglas Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on neXus I, II and III Rollators

February 2, 2010

Subject: Recall of neXus I, II and III Rollators due to potential health and safety risk

Dana Douglas Inc. has initiated a voluntary recall of certain neXus I, II and III rollators. Affected rollators may break during use, which could result in the user falling and suffering serious injury including bruising, broken bones or death. Rollators with the serial numbers indicated in bold below are affected by this recall (serial numbers are located on the inside rear leg of rollators).

neXus 1 Model #4520 with serial numbers

• between 10000-35 and 16395-35 or the following serial numbers 16791-35, 17627-35, and 19415-35
• between 14773-35 and 16062-35
• between 16668-35 and 18640-35

neXus 2 Model #4515 with serial numbers

• between 10000-45 and 18015-45
• between 16213-45 and 17708-45
• between 19008-45 and 20735-45

neXus 3 Model #4500 with serial numbers

• between 10000-40 and 70626-40 or the following serial numbers 70761-40, 71130-40, 71136-40, 71149-40, 71150-40, 71158-40, 71160-40, 71162-40, and 71196-40
• between 66982-40 and 72867-40
• between 76025-40 and 92072-40

neXus 3 Model #4500T with tall handles and serial numbers between 91164-40 and 102792-40

Individuals are advised to stop using affected rollators immediately and to return their rollator to an authorized dealer for necessary modifications. For any questions about the recall, or to locate an authorized dealer, contact Dana Douglas by email at info@danadouglas.com or by telephone, fax or postal mail at the contact information below.

Dana Douglas has identified four potential issues with the rollators. Each issue and the serial numbers affected by the issue are discussed separately below.

1. Rollators with the Super Low, Low and Standard seat heights bearing one of the serial numbers indicated immediately below may experience a weakening below the weld on the rear frame which could result in breakage when used by consumers weighing more than 85 kilos (187 pounds).

   There have been 75 reported incidents of the rear frame breaking on the neXus 1 and 2 models of which six (6) have resulted in falls and bruising to the user. There have been 145 reported incidents of the rear frame breaking on the neXus 3 model. No injuries have resulted from the incidents involving the neXus 3 model.
   • neXus 1 Model #4520 with serial numbers between 10000-35 and 16395-35 or the following serial numbers 16791-35, 17627-35, and 19415-35
   • neXus 2 Model #4515 with serial numbers between 10000-45 and 18015-45
   • neXus 3 Model #4500 with serial numbers between 10000-40 and 70626-40 or the following serial numbers 70761-40, 71130-40, 71136-40, 71149-40, 71150-40, 71158-40, 71160-40, 71162-40, and 71196-40

   Installation of manufacturer-supplied reinforcement brackets at the rear frame weld will increase the product's weight capacity to the advertised maximum user weight of 113 kilos (250 pounds.)

   Note: Rollators distributed since October 30, 2009 are rated for use by customers up to 113 kilos (max. 250 pounds.)
2. The front fork bearing on rollators with the serial numbers indicated immediately below, may loosen causing the front wheel to fall off the neXus frame when the rollator is raised off the ground. There have been nine (9) reported incidents in which the front wheel has fallen off the frame. No injuries have resulted from these incidents.
   • neXus 1 Model #4520 with serial numbers between 14773-35 and 16062-35
   • neXus 2 Model #4515 with serial numbers between 16213-45 and 17708-45
   • neXus 3 Model #4500 with serial numbers between 66982-40 and 72867-40
3. The front wheel forks on rollators with the serial numbers indicated immediately below may crack with usage which may ultimately lead to breakage. There have been twenty-one (21) reported incidents of the front wheel fork cracking or breaking. No injuries have resulted from these incidents.
   • neXus 1 Model #4520 with serial numbers between 16668-35 and 18640-35
   • neXus 2 Model #4515 with serial numbers between 19008-45 and 20735-45
   • neXus 3 Model #4500 with serial numbers between 76025-40 and 92072-40
4. The brake on neXus 3 Model #4500T rollators with tall handles and serial numbers between 91164-40 and 102792-40 could jam in the locked position and not release resulting in the user being unable to move the rollator. There have been five (5) reported incidents of the brake jamming in the locked position during use. No injuries have resulted from these incidents.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported postmarket adverse incidents are generally presumed to underestimate the risks associated with health product use. Any cases of falls resulting in bruising, broken bones or death or other serious or unexpected adverse incidents in persons using neXus rollators should be reported to Dana Douglas Inc. or Health Canada at the following addresses: