Devices

Device Recall OPT Croutons synthetic bone substitute

Model / Serial
lot 549/12.001. Part number 65-0210-S.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
Product Description
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Manufacturer
Acumed LLC
1 Event
- Recall of Device Recall OPT Croutons synthetic bone substitute

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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