FDA (Devices) recall action 89520
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.
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
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.
Howmedica Osteonics is recalling Exeter V40 Cemented Hip (125mm) Stem devices due to a potential label mix with 150mm stems. Incorrect labeling could result in wrong implant size being used during surgery.
The FDA has recalled Exeter V40 Cemented Hip (150mm) Stems due to a potential labeling mix-up with the 125mm version. Patients who received the device should verify with their surgeon that the correct size was implanted.