Z-1334-2011

S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger GmbH & Co. Freiburg...

Name: Z-1334-2011 S T-Bone Plate; M T-Compression Plate; Manufactured and Distributed by Stryker Lebinger GmbH & Co. Freiburg...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-05-26
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-05-26 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2006-05-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1334-2011
Status: Terminated
Initiated: 2006-05-26
Posted: 2011-02-16
Terminated: 2014-12-08
Recalling firm: Howmedica Osteonics Corp
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 21
Distribution: Nationwide Distribution
Product codes and lots: S T-Bone Plate, Product number: 57-05260; Lot Code G4M 00F1576; M T-Compression Plate, Product number 57-10260; Lot Code G4N00F1584

Product code HRS

K062498Class IIProfyle SystemHowmedica Osteonics Corp. / cleared 2006-10-25

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)