Z-0052-2020Class II

K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)

Name: Z-0052-2020 K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)
Creator: K2M, Inc
Published: 2016-12-02
License: https://open.fda.gov/license/

K2M, Inc / initiated 2016-12-02 / Terminated / root cause: manufacturing process

FDA source

K2M, Inc began a recall of K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional... on 2016-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0052-2020
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2019-10-07
Terminated: 2020-05-22
Recalling firm: K2M, Inc
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.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: All product lots in distribution as of December 1, 2016, are in scope.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0052-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0052-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code OLO

K171321Class IIK2M Navigation InstrumentsK2m / cleared 2017-08-30

MDM coverage of this record lists here, newest first.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)