CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

8450-009-030 Precision Round, single use recalled

Stryker Instruments Div. of Stryker is recalling 8450-009-030 Precision Round, single use, Sterile The Stryker MIS (Minimally Invasive, distributed nationwide in the US. The recall was initiated on 30 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number:16032017, Product Number: 8450-009-030

Quantity recalled1,257 in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0873-2017
FDA event ID: 75819
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2016
FDA classified: 21 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

30 Nov 2016	Recall initiated by company
21 Dec 2016	Classified by FDA	+21 days
28 Dec 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.

Where it was distributed

Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).

Nationwide Alaska Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri North Carolina

Questions about this recall

Why was it recalled?

Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Which lots are affected?

Lot Number:16032017, Product Number: 8450-009-030

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 75819

This product is part of a recall event; the main page for the event is 8470-009-040 Precision Round, single use recalled.

Reported	Class	Recall	Company	Reason	Where
28 Dec 2016	CLASS II	8470-009-040 Precision Round, single use recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
28 Dec 2016	CLASS II	8450-107-530 Precision Match Head, single use recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
28 Dec 2016	CLASS II	8470-009-030 Precision Round, single use recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
28 Dec 2016	CLASS II	8450-010-040 Round, single use, Sterile The Stryker MIS recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
28 Dec 2016	CLASS II	8450-107-525 Precision Match Head, single use recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
28 Dec 2016	CLASS II	8450-009-040 Precision Round, single use recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide

More recalls from Stryker Instruments Div. of Stryker

All 161

Reported	Class	Recall	Company	Reason	Where
27 Jul 2022Device	CLASS III	Triton Sponge System recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	Triton Canister System (finished part numbers FG recalled	Stryker Instruments Div. of Stryker	Device Malfunction	Nationwide
27 Jul 2022Device	CLASS II	SurgiCount+ System Application recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Device Malfunction	KS, ME
18 Nov 2020Device	CLASS II	Stryker Zyphr Disposable Cranial Perforator recalled	Stryker Instruments Div. of Stryker	Foreign Material	Nationwide
6 May 2020Device	CLASS II	Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	MI

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All 3,809

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9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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