Z-0869-2017 Class II Terminated
FDA device recall Z-0869-2017 was initiated by Stryker Instruments Div. Of Stryker Corporation on Nov 30, 2016 and is designated Class II. Reason for recall: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. The recall status is terminated (terminated Jun 1, 2017). Affected quantity: 1,257 in total.
Recall details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Nov 30, 2016
- Termination Date
- Jun 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,257 in total
Product description
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.
Reason for recall
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
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).
Code information
Lot Number:16056017, Product Number: 8450-107-525
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0869-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026