Recall Z-0192-2016 ยท EZX Mesh, Surgical, Metal
Synthes (USA) Products LLC
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
| Date | Oct 7, 2015 |
| Status | Terminated |
| Reason | The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your na |
| Quantity | 25 |
| Distribution | Worldwide distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.