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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
S T-Bone Plate, Product number: 57-05260, Lot Code G4M 00F1576, M T-Compression Plate, Product number 57-10260, Lot Code G4N00F1584
Products Sold
S T-Bone Plate, Product number: 57-05260; Lot Code G4M 00F1576; M T-Compression Plate, Product number 57-10260; Lot Code G4N00F1584
Stryker Howmedica Osteonics Corp. is recalling S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger GmbH & Co. F due to 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 57-1. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Accountability Form and fax a copy of the form to 201-831-6069 within 5 days of receipt of the notice. Customers were asked to return the affected product via Inter-Org Transfer and ship to Product Surveillance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, USA 07430-2104. Customers were also instructed to contact their Stryker Orthopaedics Customer Service representataive to re-order the product that they were returning. For questions regarding this recall call (201) 831-5825.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026