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U.S. Department of Health and Human Services

Class 2 Device Recall CHESAPEAKE (10 mm Drill Guide Inserter CERVICAL COMPONENT)

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  Class 2 Device Recall CHESAPEAKE (10 mm Drill Guide Inserter CERVICAL COMPONENT) see related information
Date Initiated by Firm March 16, 2021
Create Date April 12, 2021
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-1410-2021
Recall Event ID 87565
510(K)Number K111439  
Product Classification Plate, fixation, bone - Product Code HRS
Product Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine)
Catalog number: 3608-90033
Code Information Lot Number: MNAJ GTIN: 10888857082571
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = K2M, INC.
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