Z-0331-2011

Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325...

Name: Z-0331-2011 Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-08-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-08-30 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The nail holding... on 2010-08-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0331-2011
Status: Terminated
Initiated: 2010-08-30
Posted: 2010-11-09
Terminated: 2012-08-21
Recalling firm: Howmedica Osteonics Corp
Product: Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The nail holding Screw is used to assemble the nail to the target device. The Nail holding Screw is further the mating part (inner thread) of the External Compression Device as the instruments needs to be threaded into the Nail holding Screw in order to achieve Compression at the fracture side.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 22
Distribution: Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
Product codes and lots: Catalog Number: 1806-1602; Lot codes: K101924, K240627.

Product code HSB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)