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Devices
Trial Adaptor Head
Model / Serial
Lot Numbers: 14AA146 and 14AA153
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
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.
Product Description
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.
Manufacturer
Limacorporate S.p.A
1 Event
Recall of Trial Adaptor Head
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Manufacturer
Limacorporate S.p.A
Manufacturer Address
Limacorporate S.p.A, Via Nazionale 52, San Daniele Del Friuli Italy
Manufacturer Parent Company (2017)
Emil Holding Ii Sarl
Source
USFDA
Language
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