FDA (Devices) recall action 80188
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
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 M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling 58 M/L Taper Hip Prostheses distributed to Japan due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.
Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses because black residue was found in the polyethylene packaging. The firm states the residue is biocompatible, but it may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue may be present in the packaging.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to black residue found in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.
Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but risks include surgical delays or wear-related intervention.