Trilliant Surgical Recalls 8mm Hammer Toe Reaming Kits Due to Incorrect Contents
Trilliant Surgical is recalling 117 units of 8mm HTR Sterile Hammer Toe Reaming Kits because they may contain two identical reamers instead of one concave and one convex reamer.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect kit contents (missing a specific reamer type) rather than a direct safety hazard like contamination or structural failure, fitting the criteria for moderate severity.
Plain-English summary
Trilliant Surgical, LLC is recalling 117 units of the 8mm HTR Sterile Hammer Toe Reaming Kit (Part Number: 220-08-003, Lot Number: TSL007202). The recall was initiated because the firm identified that kits from this specific lot have the potential to contain incorrect contents.
The kit is designed to contain two reamers total: one Concave Reamer and one Convex Reamer. However, there is a potential that the recalled kits may contain two of the same reamer type instead of one of each. The affected products are made of stainless steel and are sterile. The expiration date for the recalled lot is 12/25/2023.
The recalled products were distributed to distributors in 21 states: AR, AZ, CA, FL, GA, IA, IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI. Consumers and healthcare providers should stop using the affected kits and contact Trilliant Surgical for further instructions.
The recalled product
- Product
- 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
- Manufacturer
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 117
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)
- Part Number: 220-08-003
- Lot Number: TSL007202
- Expiration Date: 12/25/2023.
Distribution
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