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
Filler, bone void, calcium compound - Product Code MQV
원인
A recent shipment carrying norian srs was lost by the carrier. since the product was lost before final product release testing, synthes is unable to confirm that part number srs-005-fsp- lot number n001101 meets final product release requirements. the product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
조치
All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.
Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.
제품 설명
SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. || Bone void filler.