The Recall Desk

FDA (Devices) recall action 71972

Limacorporate S.p.A recalled 2 products on 2015-09-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-09-09
Critical
0
Units
203

Why these products were recalled

The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues

    Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.

    Product
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
    Category
    Distribution
    16 states
  • ModerateFDA (Devices)··2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues

    Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.

    Product
    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
    Category
    Distribution
    16 states