Recall Z-1919-2016— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-05-02, terminated 2016-12-09. It names 2 FDA 510(k) clearances: K062789, K030069. Product: 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 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.. Reason: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-02
- Terminated
- 2016-12-09
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K062789 — SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
- K030069 — SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 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.
Reason for recall
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Data sourced from openFDA. This site is unofficial and independent of the FDA.