U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Orthosis, limb brace - Product Code IQI
원인
Ossur americas is recalling , knee shield / patella cup, knee undersleeve gray, necloc extrication collar, rebound cartilage, rebound cartilage custom, rebound air walker, rebound diabetic walker, back support suspenders clip on black, back support suspenders sew on black, extreme custom, unloader custom xt, unloader custom lite, unloader custom, and papoose infant spine immobilizers because the p.
조치
The firm sent out customer notification letters on 02/26/16.
The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to
safetyalerts.ossur.com. Should customers require ¿ssur to provide pre-printed notices for existing inventory, contact ¿ssur customer service.
For the ¿ssur Miami J¿ Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack.
Recipients of the notice with should take the following actions:
1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred.
2. Maintain awareness on this notification for an appropriate period.
3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter.
4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies.
5. To verify have received the notification, visit safetyalerts.ossur.com to complete the Response Survey.
If any questions, contact ¿ssur Customer Service at (800) 233-6263.
The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions:
Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ¿ssur.
If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.
U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
제품 설명
Unloader Custom Lite || Product Usage: || Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.