Z-2080-2008

Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures

Name: Z-2080-2008 Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-08-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-08-17 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures on 2005-08-17. The reason FDA records is "Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector". 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-2080-2008
Status: Terminated
Initiated: 2005-08-17
Posted: 2008-09-16
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
Product: Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
Product code: JEC Component, Traction, Invasive
Reason for recall: Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
Root cause tag: design
FDA root cause: Device Design
Action: Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.
Quantity in commerce: 105 units
Distribution: The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
Product codes and lots: Catalog Number: 4940-9-810: Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896.

Product code JEC

K971755Class IIHoffmann II Compact External Fixation SystemHowmedica Corp. / cleared 1997-07-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)