Z-0160-2022 Class II Terminated
FDA device recall Z-0160-2022 was initiated by Limacorporate S.p.A on October 1, 2021 and is designated Class II. Reason for recall: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included. The recall status is terminated (terminated June 27, 2024). Affected quantity: 200 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- June 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product Description
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Reason for Recall
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Distribution Pattern
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.
Code Information
2103825