Recall Z-0068-2018 ยท LXH Orthopedic Manual Surgical Instrument
Limacorporate S.p.A
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
| Date | Sep 8, 2017 |
| Status | Completed |
| Reason | 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. |
| Root cause | Vendor change control |
| Action | The Firm, Lima Corporate has notified the US agents of the recall and asked to check each single set with the affected product codes, identify the items and remove them from the inventory. The US distributors have also been instructed to fill out and sign a response document specifying the quantities returned. For further questions, please call (800) 962-2578. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141395 | DELTA TT ACETABULAR SYSTEM Lima Corporate S.P.A., Jun 30, 2014 |