Devices

Device Recall Biotrak Resorbable Fixation System

Model / Serial
Lot W67385, Model #30170320-S, expiration 8/2010 (two side labels correctly state 30170320-S, Lot W67385; top label may incorrectly state 30170060-S, lot W67391).
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA and South Africa.
Product Description
Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. || The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.
Manufacturer
Acumed LLC
1 Event
- Recall of Device Recall Biotrak Resorbable Fixation System

Manufacturer

Acumed LLC

Manufacturer Address
Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
Manufacturer Parent Company (2017)
Acumed Llc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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