FDA (Devices) recall action 89321
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.
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
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.
Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.