FDA (Devices) recall action 78706
The FDA (Devices) publishes a recall like this one as 48 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 48 pages.
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
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 specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling NEXGEN LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling specific hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 Versus 8 Inch Beaded hip implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling specific hip implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling 13,227 patella femoral joint implants because LDPE bag packaging may leave residue on the polished surface.
Zimmer Biomet is recalling NEXGEN GSF Porous Femoral LPS Flex implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.
Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.
Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.