FDA Device recall Z-1918-2016
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Flo…
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Flo… by Synthes Usa Products, citing labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1918-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-02 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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.
Reason
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Identifiers
| code_info | Catalog # 851.689.01S, Lot # 7672066 and 7672089 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1918-2016%22
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