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Synthes (USA) Products LLC recalls 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Re
Recalled June 15, 2016 · FDA recall Z-1920-2016 · Synthes (USA) Products
Hazard
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. · FDA Class II
Units
14 units
Sold at
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Description
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Product
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →