The Recall Desk
SevereFDA (Devices)·Z-2027-2020·Announced 2020-05-27

K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (tip breakage) in a surgical instrument, which poses a significant risk of injury during a procedure.

Plain-English summary

K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader, a stainless steel, non-sterile medical device used to simulate cage height and expand spine disc space. The recall involves Lot # FKXT, distributed worldwide including in the United States and Europe.

The device was manufactured as two pieces welded together. This design has been associated with the spreader tip breaking off during the procedure. The source text does not specify the number of affected units or report any specific patient injuries.

Healthcare providers should stop using the affected devices and contact K2M, Inc. for instructions on return or replacement.

The recalled product

Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Manufacturer
K2M, Inc
Category
Medical Device — Surgical Instrument
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # FKXT

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 24 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

Related recalls

Same manufacturer · K2M, Inc

See all →

Same hazard · structural failure

See all →