FDAClass IIDecember 27, 2023

LITe Decompression Snake Arm recall

LITe Decompression Snake Arm, REF 48080230

Why was LITe Decompression Snake Arm recalled?

Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (GTIN): 07613327263909, lot # 227764.

Product
LITe Decompression Snake Arm, REF 48080230
Recalling firm
Stryker Spine
Quantity
9
Distribution
US: MD, MI, NM, TX & OUS: Canada & France.
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls