FDAClass IIOctober 20, 2021

Chesapeake Anterior Lumbar recall

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

Why was Chesapeake Anterior Lumbar recalled?

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lots CCUNA, HYMJ, KNCU

Product
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Recalling firm
K2M, Inc
Quantity
23
Distribution
Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
Recall date
October 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls