FDA-Device2016-06-15Class II
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Synthes (USA) Products LLC
Hazard
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Sold states
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Affected count
14 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1920-2016Don't want to check this manually?
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