Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk
Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' severity category per the rubric.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 1,420 units of EliteCore Full Core Biopsy Devices. The affected models include EliteCore 18G devices in 20cm, 15cm, and 10cm lengths, with and without HiLiter tips. The recall covers Stryker product numbers 0915-820-000, 0905-820-000, 0915-815-000, 0905-815-000, 0915-810-000, and 0905-810-000, as well as RLS product numbers 931018, 931518, and 941518.
The recall is due to a potential for the device cannula to overthrow past the intended length. This defect could pose a risk to patients during biopsy procedures. The FDA has classified this as a Class II recall.
The affected devices were distributed nationwide in the United States, including in Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Wisconsin. Stryker lot numbers distributed between June 16, 2014, and February 10, 2015, and RLS lot numbers distributed between March 28, 2013, and June 16, 2014, are affected. Healthcare facilities should stop using these devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Biopsy Device
- Hazard
- Affected units
- 1,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Stryker Product Numbers: 0915-820-000
- 0905-820-000
- 0915-815-000
- 0905-815-000
- 0915-810-000
- 0905-810-000
- RLS Product Numbers: 931018
- 931518
- 61406002
- 61203001
- 61108001
- 61208002
- 61309001
Distribution
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