Recall Z-0868-2017— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2016-11-30, terminated 2017-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-30
- Terminated
- 2017-06-01
- Firm location
- Portage, MI, United States
Product description
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.
Reason for recall
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.