Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''. 의 리콜
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
데이터 추가 비고
원인
Linvatec has determined there is a possibility the pouch tyvek header to foil longitudinal seal was not properly sealed by bemis flexible packaging, in all pouches, prior to sterilization by linvatec. therefore there is a potential for compromised sterility of the devices.
조치
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
제품 설명
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.