The Recall Desk
HighFDA (Devices)·Z-2339-2018·Announced 2018-07-11

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.

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 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
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 →