Reported Nov 18, 2015 · Terminated
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES.…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
- Lot codes and dates
- 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
- Amount recalled
- 20,494
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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