FDA-Device2015-09-09Class II
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.
Limacorporate S.p.A
Hazard
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Sold states
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.
Affected count
93 units
Manufactured in
Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, Italy
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2015Don't want to check this manually?
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