Limacorporate S.p.A recalls SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor,…

Recall date

August 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2540-2015

FDA classification

Class II

Brand / firm

Limacorporate S.p.A

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.