Recall Z-0992-2014
Synthes, Inc. · initiated January 27, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
Codes / lots: part No. 03.503.043, lot #7908431
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.
FDA-determined cause: Process control
Action taken
A recall letter, dated January 27, 2014, was sent to end users and sales consultants.
Details
- Recall number
- Z-0992-2014
- Initiated
- January 27, 2014
- Posted by FDA
- February 19, 2014
- Terminated
- July 20, 2015
- Product code
- FZX – Guide, Surgical, Instrument
- Quantity
- 12
- Distribution
- US distribution to MI, TX, and CA.
- Recalling firm
- Synthes, Inc., West Chester, PA