Synthes Small Notch Titanium Reconstructive Plate Product Usage: The… — Class II medical device recall Z-1174-2014
Terminated recall by Synthes, Inc., reported 2014-03-19, distributed nationwide. Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine
| Recall number | Z-1174-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-01-27 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 18,747 |
| Model numbers | 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, 489.425 |
Product
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Reason for recall
Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
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-1174-2014. 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.