FDA (Devices) recall action 77911
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
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 Thread Retrieval Drills because they were shipped without supplemental instructions for use.
Zimmer Biomet is conducting a field correction for dental impression caps because they were shipped without supplemental instructions for use.
Zimmer Biomet is recalling dental waxing copings because they were shipped with only standard instructions, missing required supplemental IFUs.
Zimmer Biomet is recalling 169 dental implants because they were shipped without supplemental instructions for use.
Zimmer Biomet is recalling specific dental guide sleeves because they were shipped with only standard instructions, missing required supplemental instructions.
Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.
Zimmer Biomet is correcting dental abutments and copings because they were shipped with standard instructions but missing supplemental instructions.