Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation

Device recall: Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy D

FDA enforcement event 71429 · Class II · initiated 2 Jun 2015 · status Terminated · terminated 3 Sep 2015

DeviceVoluntary: Firm initiated1 product recordPortage, MI

Stryker Instruments Div. of Stryker Corporation (Portage, MI) initiated this device recall on 2 Jun 2015; FDA lists 1 product record under event 71429, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 3 Sep 2015. Initiation: voluntary: firm initiated. Stryker Instruments Div. of Stryker Corporation has 55 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Stryker Instruments Div. of Stryker Corporation, Portage, MI.

Reason for recall

"Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation."

Distribution

"US Nationwide Distribution in the states of: TX, NJ and MS."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2102-2015	Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for…	55 units	Class II	Terminated	29 Jul 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

55events on this register for the firm

Other enforcement events for Stryker Instruments Div. of Stryker Corporation

Initiated	Product (first record)	Type	Class	Records
15 Jun 2022	SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, rec	Device	Class II	1
16 Oct 2020	Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cut	Device	Class II	1
26 Mar 2020	Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smo	Device	Class II	1
22 Jan 2020	Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label	Device	Class II	1
13 Jan 2020	SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches lo	Device	Class II	3
6 Nov 2019	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connecto	Device	Class II	2
31 Jul 2019	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for	Device	Class II	2
19 Mar 2019	Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are	Device	Class II	1
4 Dec 2018	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	Device	Class III	1
23 Feb 2018	T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment	Device	Class II	11

All 55 events for Stryker Instruments Div. of Stryker Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution in the states of: TX, NJ and MS."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 Sep 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.