Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5...
FDA Device Recall #Z-0236-2016 — Class II — October 8, 2015
Recall Summary
| Recall Number | Z-0236-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 8, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes (USA) Products LLC |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 20,494 |
Product Description
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.
Distribution Pattern
US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY.
Lot / Code Information
Product Number Lot Number 489.401 4548779, 4545040, 4705188, 5106917 489.402 3949751 thru 6746734 A4FB851 thru A4JY300 489.403 3949753 thru 7097983 A4FB853 thru A4JV500 489.412 3950191 thru 6411381 A4FC274 thru A4JV496 489.413 3949756 thru 6819450 A4FB849 thru A4JR743 489.414 3929795 thru 6664281 A3JC152 thru A4JS596 489.415 3950185 thru 7464249 A4FB848 thru A4JS745 489.418 3949761 thru 7340734 A4FB855 thru A4JY299 489.423 3950186 thru 6714781 A4FC276 thru A4JJ712 489.424 3950189 thru 6714771 A4FB850 thru A4JV658 489.425 3173963 through 5836149 A4FC253 through A4JQ261
Other Recalls from Synthes (USA) Products LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0228-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM... | Sep 26, 2025 |
| Z-0229-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM... | Sep 26, 2025 |
| Z-1916-2024 | Class II | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/... | Apr 25, 2024 |
| Z-1239-2024 | Class II | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... | Jan 24, 2024 |
| Z-1238-2024 | Class II | RAPIDSORB IPS Battery Pack, Sterile-Intended fo... | Jan 24, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.