Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
It has come to acumed's attention that some of its products have been distributed in canada without a valid medical device licence issued by health canada. acumed is recalling these products from canada only.
Model Catalog: HR-0001-S (Lot serial: NA); Model Catalog: PL-PHXGL (Lot serial: NA); Model Catalog: PL-PHXGR (Lot serial: NA); Model Catalog: PL-2127 (Lot serial: NA); Model Catalog: PL-MCPL (Lot serial: NA); Model Catalog: ATF-200-S (Lot serial: NA); Model Catalog: ATF-180-S (Lot serial: NA); Model Catalog: ATF-160-S (Lot serial: NA); Model Catalog: ATF-140-S (Lot serial: NA); Model Catalog: 70-0096-S (Lot serial: NA); Model Catalog: 70-0095-S (Lot serial: NA); Model Catalog: 30-0033-S (Lot serial: NA); Model Catalog: ATF-220-S (Lot serial: NA); Model Catalog: PL-MCPR (Lot serial: NA); Model Catalog: PL-SR27 (Lot serial: NA); Model Catalog: PL-SR39 (Lot serial: NA); Model Catalog: PL-SR40 (Lot serial: NA); Model Catalog: PL-SR41 (Lot serial: NA)
제품 설명
POLARUS CAP SCREW ASSEMBLY;PROXIMAL HUMERAL PLATE EXTRA LONG;CONGRUENT BONE PLATE SYSTEM - DRILL GUIDE;1ST MCP FUSION PLATE;ACUTRAK FUSION DEVICE;LOCKING CLAVICLE PLATE 8 HOLE STRAIGHT;CONGRUENT BONE PLATE SYSTEM - REAMER