Recall Z-0068-2018— Limacorporate S.p.A

Name: FDA recall Z-0068-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-08

Class II · Completed

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2017-09-08. It names one FDA 510(k) clearance: K141395. Product: Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System. Reason: An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Completed
Initiated: 2017-09-08
Firm location: San Daniele del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K141395 — DELTA TT ACETABULAR SYSTEMLima Corporate S.P.A.·cleared 2014-06-30

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

Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System

Reason for recall

An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.

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