REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Reported: October 27, 2021 Initiated: October 1, 2021 #Z-0159-2022
Product Description
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
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.
Details
- Recalling Firm
- Limacorporate S.p.A
- Units Affected
- 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.
- Location
- San Daniele Del Friuli, N/A
Frequently Asked Questions
What product was recalled? ▼
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852. Recalled by Limacorporate S.p.A. Units affected: 151 units.
Why was this product recalled? ▼
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0159-2022.
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