Limacorporate S.p.A: Medical Device Recall in 2017 - (Recall #: Z-0068-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 8, 2017

Date Posted: November 15, 2017

Recall Number: Z-0068-2018

Event ID: 78109

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.

Status: Completed

Product Quantity: 20 units in (US)

Code Information:

Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J

Distribution Pattern:

Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany

Voluntary or Mandated:

Voluntary: Firm initiated