Trilliant Surgical Reamer Heads Recalled for Guide Pin Fit Issues
Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the source describes a functional defect in a medical device used in surgery that poses a risk of harm, but no specific injuries or illnesses are reported in the text.
Plain-English summary
Trilliant Surgical Ltd. is recalling 638 units of Concave and Convex Reamer Heads (16 mm, 18 mm, 20 mm, and 22 mm) used with the Gridlock Plating system. These devices are intended for use in trauma and reconstructive procedures in small bones. The recall covers units distributed nationwide throughout the US.
The recall was initiated because the cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. This defect could potentially interfere with the proper use of the device during surgical procedures.
Healthcare providers and facilities that have received these products should stop using them and contact Trilliant Surgical Ltd. for instructions on return or replacement. The affected lot codes are TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, and TSL000708.
The recalled product
- Product
- Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and…
- Manufacturer
- Trilliant Surgical Ltd.
- Affected units
- 638
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 (20)
- TSL000145
- TSL000162
- TSL000699
- TSL000146
- TSL000163
- TSL000700
- TSL00147
- TSL000164
- TSL000701
- TSL000702
- TSL000148
- TSL000165
- TSL000706
- TSL000149
- TSL000166
- TSL000688
- TSL000150
- TSL000167
- TSL000707
- TSL000708
Distribution
Distributed nationwide across the United States.
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