FDA (Devices) recall action 79242
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.
For soft tissue fixation
Product may contain the presence of melted sterile packaging upon opening.
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 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.
Zimmer Biomet is recalling 30 units of DELTA CER FEM HD 32/0MM T1 hip arthroplasty components because the sterile packaging may be melted upon opening.