Recall Z-1334-2011 ยท HRS Plate, Fixation, Bone
Stryker Howmedica Osteonics Corp.
S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger GmbH & Co. Freiburg, Germany. The Profyle System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screws techniques, joint fusion, corrective osteotomies, and the treatment of fractures
| Date | Feb 16, 2011 (initiated May 26, 2006) |
| Status | Terminated |
| Reason | A package labeled as a S T-Bone Plate, Catalog Number 57-05260, Lot Code G4M00F1576, may actually contain a M T-Compression Plate, Catalog Number 57-10250, Lot Code G4N00F1584 and vice versa. |
| Root cause | Process design |
| Action | Stryker Orthopedics sent an Important Market Withdrawal letter dated May 26, 2006, by Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory, including their hospital consignment location, to identify the product. If the affected product remained in its original packaging, customers were instructed to retrieve all of the affected product lots and return it to their branch or agency warehouse for reconcillation. Reconcile all product on the attached Product Accou |
| Quantity | 21 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062498 | PROFYLE SYSTEM Howmedica Osteonics Corp., Oct 25, 2006 |