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Devices
Device Recall Intramedullary Fixation Rod
Model / Serial
Model # 40-0028-S on lot # W65318, exp: 06/2015; Model # 40-0029-S on lot # W64072, exp: 06/2015; and Model # 40-0031-S on lot # W65319 exp: 06/2015.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.
Product Description
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Manufacturer
Acumed LLC
1 Event
Recall of Device Recall Intramedullary Fixation Rod
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Manufacturer
Acumed LLC
Manufacturer Address
Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
Manufacturer Parent Company (2017)
Acumed Llc
Source
USFDA
Language
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