Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Delta Cup Beater  Positioner - Aligner Recalled by Limacorporate S.p.A Due to An internal analysis on complaints received indicated that...

Date: September 8, 2017
Company: Limacorporate S.p.A
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Limacorporate S.p.A directly.

Affected Products

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

Quantity: 20 units in (US)

Why Was This Recalled?

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.

Where Was This Sold?

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

About Limacorporate S.p.A

Limacorporate S.p.A has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report