FDA (Devices) recall action 74799
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.
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
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 Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.
Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.