Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Reported: November 15, 2017 Initiated: September 8, 2017 #Z-0068-2018
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.
Details
- Recalling Firm
- Limacorporate S.p.A
- Units Affected
- 20 units in (US)
- Distribution
- 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
- Location
- San Daniele del Friuli, N/A
Frequently Asked Questions
What product was recalled? ▼
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System. Recalled by Limacorporate S.p.A. Units affected: 20 units in (US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0068-2018.
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