Synthes 5.0mm Variable Locking Screw This device is recall: Labeling Error
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable…
Why was Synthes 5.0mm Variable Locking Screw This device is recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
part no. 02.231.240, lot no. 823111
- Product
- Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable…
- Recalling firm
- Synthes, Inc.
- 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.
- Recall date
- March 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)