Z-0191-2009

Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432...

Name: Z-0191-2009 Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-08-14
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-08-14 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by... on 2008-08-14. The reason FDA records is "Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0191-2009
Status: Terminated
Initiated: 2008-08-14
Posted: 2008-10-28
Terminated: 2012-05-29
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 007430 Reduction spoons are sold separately or as part of a kit. The Universal Rod with Reduction Spoon may be used as a fracture reduction tool to facilitate Guide Wire insertion.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.
Root cause tag: design
FDA root cause: Device Design
Action: Recall notification letters were sent on August 14, 2008 to all branches and hospitals via Federal Express. Questions are to be directed to 201-831-5718 or a Trauma team member listed in the letter.
Quantity in commerce: 1070 units
Distribution: Nationwide
Product codes and lots: Product Code 1806-0125 All product made before design change in 2003. Refer to picture provided showing differences in device.

Product code LXH

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)