Synthes Small Notch Titanium Reconstructive Plate set — Class II medical device recall Z-0236-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-11-18, distributed in AL, AR, AZ, CA, FL, IN, LA, MN…. The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and c
| Recall number | Z-0236-2016 |
|---|---|
| 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 | 2015-10-08 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-07-15 |
| Distributed | AL, AR, AZ, CA, FL, IN, LA, MN, MO, MS, NJ, NY, OH, OK, PA, VA, VT, WA |
| Quantity | 20,494 |
| Lot numbers | 3949751, 4545040, 4548779, 4705188, 489.401, 489.402, 5106917 |
Product
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Reason for recall
The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.
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-0236-2016. 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.