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
Multi-use Surgical Handle - Product Code GZT
원인
Dislodged collar spring; the collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
조치
All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.
Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.
제품 설명
Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.