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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75819

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 30, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Instruments Div. of Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

8450-107-530 3.0MM Precision Match Head, 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.

Z-0868-2017
Recall number
Z-0868-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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).

device · product 2 of 7

8450-107-525 2.5MM Precision Match Head, 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.

Z-0869-2017
Recall number
Z-0869-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number:16056017, Product Number: 8450-107-525

Distribution pattern

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).

device · product 3 of 7

8470-009-030 3.0MM Precision Round, 16CM, 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.

Z-0870-2017
Recall number
Z-0870-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number(s):16049017 & 16053017, Product Number: 8470-009-030

Distribution pattern

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).

device · product 4 of 7

8470-009-040 4.0MM Precision Round, 16CM, 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.

Z-0871-2017
Recall number
Z-0871-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number:16038017, Product Number: 8470-009-040

Distribution pattern

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).

device · product 5 of 7

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.

Z-0872-2017
Recall number
Z-0872-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number:16060017, Product Number: 8450-010-040

Distribution pattern

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).

device · product 6 of 7

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.

Z-0873-2017
Recall number
Z-0873-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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).

device · product 7 of 7

8450-009-040 4.0MM 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.

Z-0874-2017
Recall number
Z-0874-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
1,257 in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number:16029017, Product Number: 8450-009-040

Distribution pattern

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).

Field note

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