PlainRecalls
FDA Devices Moderate Class II Terminated

EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

Reported: June 3, 2015 Initiated: April 24, 2015 #Z-1671-2015

Product Description

EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

Reason for Recall

Potential for the device cannula to overthrow past the intended length.

Details

Units Affected
1,420 Units
Distribution
US Nationwide Distribution including AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, VA, and WI.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 1,420 Units.
Why was this product recalled?
Potential for the device cannula to overthrow past the intended length.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1671-2015.