Trilliant Surgical Recalls Ratcheting Cannulated Driver Handles Due to Function Degradation
Trilliant Surgical Ltd. is voluntarily recalling 90 units of Ratcheting Cannulated Driver Handles that may fail to retain the mating adapter shaft.
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 involves a medical device with a functional defect that could lead to harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Trilliant Surgical Ltd. is voluntarily recalling 90 units of Ratcheting Cannulated Driver Handles, catalog numbers 210-00-003 and 210-00-004. The recalled items are prescription-only, non-sterile medical devices manufactured by Trilliant Surgical Ltd.
The recall was initiated because the handles may demonstrate a degradation of function, specifically with the adapter collar sticking and/or not retaining the mating adapter male shaft. This defect could compromise the intended use of the surgical instrument.
The affected units were distributed to 22 U.S. states: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, and MO. The specific lot number is 603600. Healthcare facilities and consumers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
- Manufacturer
- Trilliant Surgical Ltd.
- Affected units
- 90
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 (1)
- Lot: 603600
Distribution
Part of a larger recall action
This product is one of 2 recalled by Trilliant Surgical Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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