—#94535

Product

External Compression Device; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 1806-1601; Lot code: K228113

Why it was recalled

Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.

Root cause (FDA determination)

Other

Action the firm took

Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX

Timeline

Recall initiated: 2010-08-30
Posted by FDA: 2010-11-09
Terminated: 2012-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94535. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.