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

FDA device recall Z-1334-2011 · posted 2011-02-16 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

HRS

Quantity affected

21

Distribution

Nationwide Distribution

Date initiated

2006-05-26

Date posted

2011-02-16

Date terminated

2014-12-08

Location

Mahwah, NJ

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