—#42705

Product

S2 System, Locking Screw Fully Threaded

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K021026
Affected lot / code info: Catalog No. 1796-5065S to 1796-5120S

Why it was recalled

Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.

Root cause (FDA determination)

Other

Action the firm took

The product recall will extend to all branches.agencies and hospitals that have received the product.

Recalling firm

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

Distribution

Distribution pattern: nationwide

Timeline

Recall initiated: 2005-10-04
Posted by FDA: 2005-11-18
Terminated: 2006-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.