Reported Oct 20, 2021 · Terminated

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

K2M, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428

Is this the product you have?

  • Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Lot codes and dates
  • Lots CCUNA, HYMJ, KNCU
Amount recalled
23

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 17, 2024 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.