Recall Z-2087-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes, Inc.
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
| Date | Jul 21, 2014 (initiated May 29, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 180 |
| Distribution | Distribution US Nationwide and Bermuda. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.