FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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.
- Recall number
- Z-0330-2011
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2010-08-30
- Posted
- 2010-11-09
- Terminated
- 2012-08-21
- Reason
- 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
- 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
- 11
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
- Lot, serial or model codes
- Catalog Number: 1806-1601; Lot code: K228113
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28