CLASS II Device recall · Reported 20 Oct 2021 · FDA Enforcement Report

Chesapeake Anterior Lumbar (AL) Removal Tool recalled by K2M

K2M is recalling Chesapeake Anterior Lumbar (AL) Removal Tool, distributed in 9 states. The recall was initiated on 8 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots CCUNA, HYMJ, KNCU

Quantity recalled23

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0104-2022
FDA event ID: 88630
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 8 Sep 2021
FDA classified: 13 Oct 2021
Reported: 20 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Sep 2021	Recall initiated by company
13 Oct 2021	Classified by FDA	+35 days
20 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

Colorado Illinois Louisiana Massachusetts Mississippi Oklahoma Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots CCUNA, HYMJ, KNCU

Where was it sold?

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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