Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws Recalled by SAFE ORTHOPAEDICS LLC Due to The type of screw printed on the traceability...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SAFE ORTHOPAEDICS LLC directly.
Affected Products
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Quantity: 8 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: MD
About SAFE ORTHOPAEDICS LLC
SAFE ORTHOPAEDICS LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report