Recall Z-0159-2022 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Limacorporate S.p.A
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
| Date | Oct 1, 2021 |
| Status | Terminated |
| Reason | There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. |
| Root cause | Mixed-up of materials/components |
| Action | On October 1, 2021 , Lima Corporate issued an "Urgent: Medical Device Recall" notification to all affected consignees via email. In addition to informing consignees about the recall product, the firm asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices received. Affected devices are required to be sent back to LimaCorporate together with a hard copy of the attached Response Form; 2. Fill out, sign and send the attached Response Form to the email address pms@limacorporate.com, as a confirmation that You have read and acknowledged th |
| Quantity | 151 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172456 | Bone Screws 6.5mm Lima Corporate S.P.A., Jan 4, 2018 |