Device product
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 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.
Z-1918-2016
Product summary
- Event
- Event 74053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-1918-2016
Official wording
Reason: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Code information: Catalog # 851.689.01S, Lot # 7672066 and 7672089
Distribution pattern: Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Derived failure modes
-
Unknown
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.