Recall Z-0052-2020 ยท OLO Orthopedic Stereotaxic Instrument
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.
| Date | Dec 2, 2016 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171321 | K2M Navigation Instruments K2m, Aug 30, 2017 |