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Limacorporate S.p.A recalls SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter
Recalled September 9, 2015 · FDA recall Z-2539-2015 · 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. · FDA Class II
Units
110 units
Sold at
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.
Description
The dimensions of the mating features of the recalled products are out of specification causing the device to be 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.
Manufacturer(s)
Limacorporate S.p.A
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →