Trilliant Surgical Recalls Cannulated Driver Handles Due to Function Degradation
Trilliant Surgical Ltd. is voluntarily recalling 94 cannulated driver handles that may stick or 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 2/5 (Moderate).
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: This is a voluntary precautionary recall for a functional defect (sticking/failure to retain) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Trilliant Surgical Ltd. is voluntarily recalling 94 units of the Cannulated Driver Handle, Catalog # 210-00-003. The recall also includes units of Catalog # 210-00-004. These products are prescription-only and non-sterile.
The recall is being issued because the handles may demonstrate a degradation of function. Specifically, the adapter collar may stick, and/or the device may not retain the mating adapter male shaft. The affected lot number is 603599.
The recalled products were distributed in the following 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. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
- Manufacturer
- Trilliant Surgical Ltd.
- Hazard
- Affected units
- 94
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: 603599
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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