1 — Class II medical device recall Z-1918-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-06-15, distributed nationwide. Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
| Recall number | Z-1918-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-05-02 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Reason classes | labeling |
| Lot numbers | 7672066, 7672089 |
| Model numbers | 851.689.01S |
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 for recall
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1918-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.