The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCoun
FDA device recall Z-0986-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
- Action taken
- On 6/16/2013, Improvements to the SurgiCounter" charging base notifications were emailed to the affected users with instructions for requesting a replacement product. The notification included a description of the reason for the recall, affected product, and instructions for responding to the notification. For questions, call the Support team any time at (877) 520-2300 option 1, or support@scmd.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LWH
- Quantity affected
- 3625
- Distribution
- US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Date initiated
- 2013-06-16
- Date posted
- 2015-01-15
- Date terminated
- 2015-08-20
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICOUNT SAFETY-SPONGE SYSTEM (K060076) | Surgicount Medical | 2006-03-14 |