ClearanceBrief
Recall Z-0256-06 ยท NDH Nail, Fixation, Bone, Metallic

Stryker Howmedica Osteonics Corp.

Long Length Dyax Nail.

DateDec 1, 2005 (initiated Sep 7, 2004)
StatusTerminated
ReasonStryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
Root causeOther
ActionThe firm sent out notification letters via FedEx on 9/7/2004 with return receipt.
Quantity4
DistributionThe devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K013468LONG LENGTH DYAX NAIL
Howmedica Osteonics Corp., Nov 16, 2001