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 patient anatomy.
Reported: May 27, 2020 Initiated: April 13, 2020 #Z-2020-2020
Product Description
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 patient anatomy.
Reason for Recall
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.
Details
- Recalling Firm
- K2M, Inc
- Units Affected
- N/A
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.
- Location
- Leesburg, VA
Frequently Asked Questions
What product was recalled? ▼
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 patient anatomy.. Recalled by K2M, Inc. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2020-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11