SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Check against the official notice below — it lists the full affected range.
Safe Orthopaedics LLC is recalling SteriSpine PS kits of 2 Multi-Axial Fenestrated Screws (model numbers KITM640, KITM645, and KITM740) due to incorrect screw type information printed on the patient traceability record label, while the screw type is correctly identified on all other labeling. A total of 8 devices were distributed to medical facilities with no government or military distribution.
The affected lot numbers are: KITM640 (Lots BF0A07 and 15BF001/R10, UDI 03760219910053), KITM645 (Lot BG0A02, UDI 03760219910060), and KITM740 (Lot BL0A01, UDI 03760219910091). The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
Reason for recall: The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct. Distribution: Distribution was made to MD. There was no government/military distribution. Quantity: 8 devices Lot/code info: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.