FDA (Devices) recall action 68817
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
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, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.
Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.