ClearanceBrief
Recall Z-0167-06 ยท HWC Screw, Fixation, Bone

Stryker Howmedica Osteonics Corp.

S2 System, Locking Screw Fully Threaded

DateNov 18, 2005 (initiated Oct 4, 2005)
StatusTerminated
ReasonStryker 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 causeOther
ActionThe product recall will extend to all branches.agencies and hospitals that have received the product.
Quantity2465 units
Distributionnationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K021026S2 FEMORAL NAIL
Howmedica Osteonics Corp., Apr 25, 2002