Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm Recalled by Limacorporate S.p.A Due to The dimensions of the mating features of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Limacorporate S.p.A directly.
Affected Products
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.
Quantity: 110 units
Why Was This Recalled?
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Where Was This Sold?
This product was distributed to 16 states: AL, CA, CO, FL, KS, LA, MI, MN, MO, MT, NV, NY, NC, OH, TX, WA
About Limacorporate S.p.A
Limacorporate S.p.A has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report