Recall Z-0406-2014 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
| Date | Nov 27, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. |
| Root cause | Labeling mix-ups |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450. |
| Quantity | 13 |
| Distribution | Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001941 | SYNTHES MODULAR FOOT SYSTEM Synthes (Usa), Sep 22, 2000 |