Recall Z-1125-2014
Synthes, Inc. · initiated February 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: part no. 02.231.240, lot no. 823111
Reason for recall
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).
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1125-2014
- Initiated
- February 5, 2014
- Posted by FDA
- March 4, 2014
- Terminated
- August 31, 2015
- Product code
- JDP – Condylar Plate Fixation Implant
- Quantity
- 45
- Distribution
- 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.
- Recalling firm
- Synthes, Inc., West Chester, PA