Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
FDA Recall Z-2080-2008 · Posted 2008-09-16
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJEC
Date Initiated2005-08-17
Date Terminated2008-09-24
Product Quantity105 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.