K2M, Inc: Medical Device Recall in 2019 - (Recall #: Z-0052-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 2, 2016

Date Posted: October 16, 2019

Recall Number: Z-0052-2020

Event ID: 83777

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.

Status: Terminated

Product Quantity: 503

Code Information:

All product lots in distribution as of December 1, 2016, are in scope.

Distribution Pattern:

US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA

Voluntary or Mandated:

Voluntary: Firm initiated