Recall Z-0397-2018 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragment
| Date | Dec 11, 2017 |
| Status | Terminated |
| Reason | Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa |
| Root cause | Mixed-up of materials/components |
| Action | The firm, Smith & Nephew, Inc., sent an "Urgent Medical Device Recall Notice" letter dated December 11, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory, locate unused devices and quarantine immediately; if you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out; return product, and complete and return the response form by email to FieldActions@smith-nephew.com or fax to 901-566-7975 even if you have not product to return. If you |
| Quantity | 2 units |
| Distribution | US Distribution to states of: MI, GA, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132886 | SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM Smith & Nephew, Inc., Feb 4, 2014 |