Z-0068-2018 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- September 8, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units in (US)
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.
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
Code Information
Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J