FDA (Devices) recall action 65800
The FDA (Devices) publishes a recall like this one as 21 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 21 pages.
The trial stems were manufactured using the wrong design.
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.
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling nine trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.