Recall Z-1711-2016— Limacorporate S.p.A

Name: FDA recall Z-1711-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Class II · Terminated

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2016-04-08, terminated 2016-12-05. It names one FDA 510(k) clearance: K110598. Product: SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.. Reason: Complaints of intra-operative breakage of the glenosphere impactors/extractors..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Terminated: 2016-12-05
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K110598 — SMR REVERSE SHOULDER SYSTEMLima Corporate S.P.A.·cleared 2011-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.