2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applicat
FDA device recall Z-2238-2016 · posted 2016-07-19 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
- Action taken
- Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 3,163
- Distribution
- Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
- Date initiated
- 2016-06-24
- Date posted
- 2016-07-19
- Date terminated
- 2017-03-23
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Stryker Footed Attachments and Cutting Accessories (K143399) | Stryker Corp. | 2015-05-08 |