—#70995

Product

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

FDA product code: JEC — Component, Traction, Invasive
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K971755
Affected lot / code info: Catalog Number: 4940-9-810: Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896.

Why it was recalled

Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide

Timeline

Recall initiated: 2005-08-17
Posted by FDA: 2008-09-16
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.