Synthes Recalls Small Notch Titanium Reconstructive Plate Sets
Synthes is recalling Small Notch Titanium Reconstructive Plate sets because they are being used in spine surgeries, which is a contraindicated use for these trauma products.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (orthopedic implant) being used in a contraindicated manner (spine surgery), which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling 20,494 units of the Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). These orthopedic implants were originally released for sale as trauma products in 1996 with specific trauma indications. The product was contraindicated for certain spine applications.
In 1999, a module containing a small offering of the SNTRP plates was released. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which is a contraindicated use. The affected units were distributed to the states of MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA, and NY.
Healthcare providers should stop using the affected SNTRP sets for spine surgeries. Patients who have had these implants placed in spine surgeries should contact their healthcare provider for evaluation. The recall is classified as FDA Class II.
The recalled product
- Product
- Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 20,494
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Number Lot Number 489.401 4548779
- 4545040
- 4705188
Distribution
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