Z-1410-2021Class II

Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior...

Name: Z-1410-2021 Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior...
Creator: K2M, Inc
Published: 2021-03-16
License: https://open.fda.gov/license/

K2M, Inc / initiated 2021-03-16 / Terminated

FDA source

K2M, Inc began a recall of Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033 on 2021-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1410-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-16
Posted: 2021-04-12
Terminated: 2021-08-12
Recalling firm: K2M, Inc
Product: Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Product code: HRS Plate, Fixation, Bone
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
FDA root cause: Under Investigation by firm
Action: Stryker Spine issued Urgent Medical Device Recal letter that issued on 3/16. Letter states reason for recall, health risk and action to take: Our records indicate Stryker previously distributed catalog no. 3608-90033, Lot MNAJ to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply Form found on the following page and return it to the email address referenced on the form. If you have any questions or concerns, please contact Stryker Spine Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing this action by the target date March 19, 2021.
Quantity in commerce: 1 unit
Distribution: PA
Product codes and lots: Lot Number: MNAJ GTIN: 10888857082571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1410-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1410-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-12

Product code HRS

K111439Class IIChesapeake (Cervical Components)K2m, Inc. / cleared 2011-08-24

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)