FDA (Devices) recall action 92210
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
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.
DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.
DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.
DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.