Synthes Guide Blocks for the 2 Column Plate 6 Hole Head recall
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Why was Synthes Guide Blocks for the 2 Column Plate 6 Hole Head recalled?
The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
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. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
- Product
- Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
- Recalling firm
- Synthes, Inc.
- Quantity
- 180
- Distribution
- Distribution US Nationwide and Bermuda.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)