Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Synthes (usa) Products Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2016.
Synthes (USA) Products LLC
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Synthes (usa) Products Llc Recall FAQ
Synthes (usa) Products Llc is the subject of a medical implants safety report: Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.. The notice was published on October 8, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 20,494 units are potentially affected.