Reported Nov 15, 2017 · Completed
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele del Friuli, N/A · N/A
Is this the product you have?
- Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
- Lot codes and dates
Lot # 15AG0HJ15AG0HQ15AG0UY15AG00P15AG04015AG08Y14AG24315AG00Q15AG0UZ15AG0V015AG0HN16AG02J
- Amount recalled
- 20 units in (US)
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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