Z-0124-2015Class II

Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer...

Name: Z-0124-2015 Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer...
Creator: Cook Medical Incorporated
Published: 2014-09-26
License: https://open.fda.gov/license/

Cook Medical LLC / initiated 2014-09-26 / Terminated / root cause: packaging

FDA source

Cook Medical Incorporated began a recall of Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar... on 2014-09-26. FDA classified it as Class II and gives the reason as "MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0124-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-10-24
Terminated: 2016-02-02
Recalling firm: Cook Medical LLC
Product: Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
Product code: KNW Instrument, Biopsy
Reason for recall: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On 9/26/2014, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and institutions Risk Managers/Recall Administration with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call Customer Relations at 1-800-457-4500 or 1-812-339-2235.
Quantity in commerce: 1239 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.
Product codes and lots: Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10; SS-10-15; SS-14-06; SS-14-10; SS-14-15. Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

Product code KNW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)