Date Initiated by Firm |
December 02, 2016 |
Create Date |
October 07, 2019 |
Recall Status1 |
Terminated 3 on May 22, 2020 |
Recall Number |
Z-0052-2020 |
Recall Event ID |
83777 |
510(K)Number |
K171321
|
Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
|
Product |
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)
Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.
|
Code Information |
All product lots in distribution as of December 1, 2016, are in scope. |
Recalling Firm/ Manufacturer |
K2M, Inc 600 Hope Pkwy SE Leesburg VA 20175-4428
|
Manufacturer Reason for Recall |
Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
K2M notified customers with a Recall Notification Letter dated December 2, 2016. The letter instructed customers to locate and segregate recalled product, complete a tracking/verification form, and return the product to K2M.
The product was reintroduced to the market after K2M obtained new 510(k) clearance for the product.
for question call at 571-919-2000 |
Quantity in Commerce |
503 |
Distribution |
US Nationwide Distribution in the states of AL
CA
CO
CT
FL
FL
IL
IN
KS
MA
MI
MN
PA
TN
TX
UT
VA |
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 = OLO and Original Applicant = K2M
|