Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive s
FDA device recall Z-0992-2014 · posted 2014-02-19 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.
- Action taken
- A recall letter, dated January 27, 2014, was sent to end users and sales consultants.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FZX
- Quantity affected
- 12
- Distribution
- US distribution to MI, TX, and CA.
- Date initiated
- 2014-01-27
- Date posted
- 2014-02-19
- Date terminated
- 2015-07-20
- Location
- West Chester, PA
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