Acumed LLC, R22-006, Locking Cortical Screw

It has come to Acumed’s attention that two batches of Acumed sterile screws were impacted by a mix-up of labeling. The part number and batch/lot number on the medical chart label inside the box are different from the part number and batch/lot number on the outer box. This was due to a supplier error at the supplier’s facility.

To date, there have been no reported incidents of injury associated with these products. A Field Safety Corrective Action (FSCA) to withdraw the following product from the field has been issued for the batches listed in the table below. The appropriate Competent Authorities have been made aware.