Recall Z-2087-2014
Synthes, Inc. · initiated May 29, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Codes / lots: part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
Reason for recall
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.
FDA-determined cause: Process control
Action taken
An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.
Details
- Recall number
- Z-2087-2014
- Initiated
- May 29, 2014
- Posted by FDA
- July 21, 2014
- Terminated
- August 18, 2016
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 180
- Distribution
- Distribution US Nationwide and Bermuda.
- Recalling firm
- Synthes, Inc., West Chester, PA