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
Instrument, compression - Product Code HWN
원인
The firm determined that the recalled instruments were manufactured using the wrong grade of material. as manufactured, the instruments are more brittle, increasing the potential for fracture.
조치
Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall.
Locate all instruments and quarantine them immediately.
Count all affected product in their territory and record the data on the
Inventory Return Certification Form included with the letter.
Fax a copy of the completed Inventory Return Form to:
Zimmer, Inc. at (574) 372-4265.
Return the recalled product along with the original completed Inventory Return Certification Form to:
Zimmer Distribution Center
Attn: Product Service
1777 West Center Street
Warsaw, IN 46580
For questions customers were instructed to contact their Zimmer Sales Representative.
For questions regarding this recall call 1 - (800) 613-6131.
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
제품 설명
Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.