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; ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2540-2015.
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2540-2015.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Limacorporate S.p.a or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2540-2015.
Limacorporate S.p.A
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Limacorporate S.p.a Recall FAQ
Limacorporate S.p.a is the subject of a medical implants safety report: 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; .... The notice was published on August 14, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 93 units are potentially affected.