FDA Device recall Z-0052-2020
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments incl…
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments incl… by K2m, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0052-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-02 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | K2m |
| Distribution | US |
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.
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.
Identifiers
| code_info | All product lots in distribution as of December 1, 2016, are in scope. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2020%22
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