FDAFDA · Food and drugs·Recall number Z-2540-2015
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.
Published September 9, 2015 · Recall initiated: August 14, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Limacorporate S.p.A
- Distributor
- US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.
- Lot
- Lot Numbers: 14AA146 and 14AA153
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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