FDA (Devices) recall action 65258
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
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 Surgical Inc is recalling 84 units of the Zimmer Air Dermatome because broken planetary gear teeth may cause the device to fail during surgery.
Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently during surgery.