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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 13 Results
510(K) Number: K043421
 
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Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 2 05/29/2019 Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 2 05/29/2019 Exactech, Inc.
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 2 05/29/2019 Exactech, Inc.
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine a... 2 03/10/2017 RTI Surgical, Inc.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and ort... 2 02/07/2014 RTI Surgical, Inc.
Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: ... 3 02/07/2006 Regeneration Technologies, Inc.
Product is 2.0 cc Opteform® RT. Product is labeled in part: ''***Processed at: Regeneration TECHNO... 3 02/07/2006 Regeneration Technologies, Inc.
Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regen... 3 02/07/2006 Regeneration Technologies, Inc.
Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Reg... 3 02/07/2006 Regeneration Technologies, Inc.
OPTEFORM® RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: ... 3 02/07/2006 Regeneration Technologies, Inc.
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