Recall Z-2020-2020 — K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patie
U.S. FDA — Device Enforcement · United States · 2020-04-13 · Class II
⚙AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Reported risk: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.