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 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 412 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Long Drills due to raw material anomalies that may increase the risk of instrument fracture.
Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 198 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.
Zimmer Biomet is recalling 173 nonsterile straight shank drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 1,250 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 1,558 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.
Zimmer Biomet is recalling 2,038 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture.
Zimmer Biomet is recalling 1,286 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 240 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.
Zimmer Biomet is recalling 171 orthopedic surgical instruments because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 453 nonsterile orthopedic drill bits because raw material anomalies may cause instrument fracture during use.
Zimmer Biomet is recalling 30 units of orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.
Zimmer Biomet is recalling 2 units of Long Drill 1/4 inch orthopedic surgical instruments due to raw material anomalies that may increase the risk of instrument fracture.
Zimmer Biomet is recalling 3,640 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 27 nonsterile orthopedic drill pilot tips because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 356 ECT Internal Fracture Fixation Drills because a raw material anomaly may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 173 orthopedic surgical instruments because a material anomaly may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 439 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 224 sterile M/DN Intramedullary Fixation Distal Drills because raw material anomalies may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 185 NCB Periprosthetic Plate System Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture during use.
Zimmer Biomet is recalling 2,825 sterile shoulder system drills manufactured with raw material anomalies that may increase the risk of instrument fracture.