Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes (USA) Products LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US, MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0236-2016
Related Recalls
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Synthes (USA) Products
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Synthes (USA) Products
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Synthes (USA) Products
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay