Recall Z-2339-2018— Trilliant Surgical Ltd.
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2018-03-27, terminated 2020-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile. Reason: Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft..
- Recalling firm
- Trilliant Surgical Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-27
- Terminated
- 2020-06-04
- Firm location
- Houston, TX, United States
Product description
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
Reason for recall
Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.
Data sourced from openFDA. This site is unofficial and independent of the FDA.