FDA (Devices) recall action 74548
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
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.
Zimmer Biomet is voluntarily recalling 169 Twist Drills because a potential tolerance stack up was identified between the drill and the mating Kirschner Wire component.
Zimmer Biomet is voluntarily recalling 169 V-Tek Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.
Zimmer Biomet is voluntarily recalling 169 V-TEK Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.
Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.