Encore Medical, LP has recalled 33 units of its EMPOWR 3D Knee Tibial Inserts because the size listed on the outside of the box may not match the component inside. Specifically, a package labeled as a 5R 16MM insert may contain a 3R 14MM insert, or vice versa. These devices are used during knee replacement surgery and were distributed to hospitals and surgical centers across 14 states. While no injuries have been reported, this mix-up can lead to delays during surgery as staff must locate a replacement for the incorrectly packaged part.
If a surgeon discovers the size discrepancy during an operation, it can cause a significant surgical delay while a correct replacement part is obtained. If an incorrectly sized insert were accidentally used, it could lead to poor joint function or the need for a secondary revision surgery.
REF: 342-16-705
REF: 342-14-703
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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