FDA (Devices) recall action 72646
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
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.
Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.
Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.
Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.
Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.