Recall Z-1949-2016 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
| Date | Jun 10, 2016 (initiated May 2, 2016) |
| Status | Terminated |
| Reason | Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur. |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes sent out an Urgent Notice to customers informing them of a package mixup and the impact it could have on users. Customers were asked to evaluate their inventory and immediately remove the affected lot (9890811) from stock. Customers were asked to call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization Number for return of the affected product, fill out the verification section of the letter and mail with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Any questions, they were said to call 610-719-5450 or to contact their DeP |
| Quantity | 6 units |
| Distribution | Distributed to one customer: Colorado |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070946 | SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES Synthes (Usa), Jun 6, 2007 |