U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Labeling correction: the package insert in one 5.0mm variable locking screw package was a gp0006 (anterior cervical vertebrae plate system) insert, which should have been a gp2848 (4.5mm va-lcp curved condylar plate system insert).
조치
Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Exchage the previously shipped package insert (GP0006) with the correct package insert (GP2848 provided with the notification).
Review the package insert.
Forward the Field Safety Notification to anyone in their facility that needs to be informed.
If the package insert has been forwarded to another facility, contact that facility.
Maintain awareness of this notice until all package inserts have been exchanged.
Maintain a copy of the notice.
Customers with questions were instructed to maintain a copy of the notice.
For questions regarding this recall call 610-719-5000.
Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.
제품 설명
Synthes 5.0mm Variable Locking Screw || This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.