medical Class II Updated 2022-08-31

SAFE ORTHOPAEDICS LLC recalls SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model

Recalled Product

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.


Hazard / Issue

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.

Issued by

FDA

Affected States: MD
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.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →