CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report

Chesapeake Cervical-Ti Drill Guide Inserter- a multi-screw recalled

K2M is recalling Chesapeake Cervical-Ti Drill Guide Inserter- a multi-screw construct providing stability, distributed in Pennsylvania. The recall was initiated on 16 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: MNAJ GTIN: 10888857082571

Quantity recalled1 unit

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-1410-2021
FDA event ID: 87565
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2021
FDA classified: 12 Apr 2021
Reported: 21 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Spinal Implants

Timeline

16 Mar 2021	Recall initiated by company
12 Apr 2021	Classified by FDA	+27 days
21 Apr 2021	Published in enforcement report	+9 days

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

Reason for recall

Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033

Where it was distributed

Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: MNAJ GTIN: 10888857082571

Where was it sold?

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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