CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
8450-010-040 Round, single use, Sterile The Stryker MIS recalled
Stryker Instruments Div. of Stryker is recalling 8450-010-040 Round, single use, Sterile The Stryker MIS (Minimally Invasive Surgery), 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
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-0872-2017
- 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
8450-010-040 4.0MM 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 AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth Carolina
Questions about this recall
Is 8450-010-040 Round, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) recalled?
Yes. Stryker Instruments Div. of Stryker recalled 8450-010-040 Round, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) on 30 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0872-2017.
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:16060017, Product Number: 8450-010-040
Where was it sold?
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).
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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