Recall Z-2539-2015— Limacorporate S.p.A

Name: FDA recall Z-2539-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-14

Class II · Terminated

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2015-08-14, terminated 2016-02-26. It names one FDA 510(k) clearance: K100858. Product: 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.. Reason: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Terminated
Initiated: 2015-08-14
Terminated: 2016-02-26
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K100858 — LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,Lima-Lto S.P.A.·cleared 2010-12-10

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 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.

Reason for recall

The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

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