Recall Z-1557-2013 ยท HRS Plate, Fixation, Bone
Synthes USA HQ, Inc.
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
| Date | Jun 19, 2013 (initiated Feb 22, 2013) |
| Status | Terminated |
| Reason | The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition. |
| Quantity | 10 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011335 | SYNTHS ONE-THIRD TUBULAR DCL PLATE Synthes (Usa), Jul 27, 2001 |