Reported Sep 9, 2015 · Terminated
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head…
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
9013.22.425 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm |
9013.22.445 | SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm |
9013.22.465 | SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm |
| — | for use in shoulder implant surgery. |
- Lot codes and dates
- Lot Numbers
14AA23414AA23514AA233
- Lot Numbers
- Amount recalled
- 110 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Limacorporate S.p.A recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.