FDA Medical Device Recalls (openFDA)
K2M, Inc: 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.
- Recall number
- Z-0052-2020
- 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.
- Status
- Terminated
- Initiated
- 2016-12-02
- Posted
- not on file
- Terminated
- 2020-05-22
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- All product lots in distribution as of December 1, 2016, are in scope.
- 510(k) numbers
- ["K171321"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3008599177
- Firm city
- Leesburg
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28