The Recall Desk
ModerateFDA (Devices)·Z-1241-2015·Announced 2015-03-11

Stryker Recalls V40 Femoral Heads Due to Assembly Issues

Stryker Howmedica Osteonics is recalling nine V40 femoral heads because they could not be assembled with their corresponding stem trunnions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional assembly defect rather than a direct safety risk like a fracture or contamination, fitting the criteria for a moderate severity score.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling nine units of LFT v40 Femoral Heads (Catalog Number 6260-9-032, Lot Code 48681201). These medical devices are designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

The recall was initiated after the company received three customer complaints regarding the same batch of V40 LFIT Vitallium femoral heads. The complaints alleged that the femoral heads could not be assembled with their corresponding V40 stem trunnions.

The affected units were distributed in the states of Georgia, Massachusetts, North Carolina, New York, and Pennsylvania. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.

The recalled product

Product
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code 48681201

Distribution

Distributed in 5 states: