FDA (Devices) recall action 93221
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.
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
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.
Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.
Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.