FDA (Devices) recall action 80195
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Trilliant Surgical Ltd. is voluntarily recalling 90 units of Ratcheting Cannulated Driver Handles that may fail to retain the mating adapter shaft.
Trilliant Surgical Ltd. is voluntarily recalling 94 cannulated driver handles that may stick or fail to retain the mating adapter shaft.