Reported Jun 1, 2016 · Terminated

SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

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?

  • SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Lot codes and dates
  • Lot numbers
    • 1390763
    • 14AA094
    • 14AA431
    • 14AA528
    • 15AA094
    • 15AA557
    • 15AA558
    • 15AA559
    • 15AA600
Amount recalled
314 units

Where it was sold

  • Nationwide

Why it was recalled

Complaints of intra-operative breakage of the glenosphere impactors/extractors.

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.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2016 · Data as of Sep 19, 6:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.