Reported Oct 16, 2019 · Terminated
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special…
K2M, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428
Is this the product you have?
- K2M Special Connector Instruments (Special Connector, Special Adaptor
- and Quick Adaptor) Product UsageSpecial 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
- Lot codes and dates
- All product lots in distribution as of December 1, 2016, are in scope.
- Amount recalled
- 503
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new K2M, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.