FDA (Devices) recall action 74687
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.
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
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 Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.
Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.