FDA (Devices) recall action 77417
The FDA (Devices) publishes a recall like this one as 60 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 60 pages.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
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 recalling 1,255 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 217 nonsterile ECT Internal Fracture Fixation Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture.
Zimmer Biomet is recalling 3,232 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 381 ECT Internal Fracture Fixation Drill bits due to raw material anomalies that may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 1,999 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 751 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 62 units of the Natural Nail System Calibrated Drill Short 4.9 mm because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 4,423 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.