FDA (Devices) recall action 81038
The FDA (Devices) publishes a recall like this one as 48 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 48 pages.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 85 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Zimmer Biomet is recalling nine Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Zimmer Biomet is recalling 12 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 39 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a contamination risk.
Zimmer Biomet is recalling 29 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed in the US and abroad.
Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 18 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 38 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Zimmer Biomet is recalling 50 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Zimmer Biomet is recalling 34 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.