CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self recalled
Limacorporate S.p.A is recalling REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self, distributed nationwide in the US. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0160-2022
- FDA event ID
- 88812
- Recalling firm
- Limacorporate S.p.A, San Daniele Del Friuli, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2021
- FDA classified
- 21 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Oct 2021 | Recall initiated by company | |
| 21 Oct 2021 | Classified by FDA | +20 days |
| 27 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Where it was distributed
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.
Nationwide CaliforniaColoradoFloridaIllinoisKansasMassachusettsMichiganMissouriNorth CarolinaNew YorkOklahomaPennsylvaniaTexas
Questions about this recall
Is REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self recalled?
Yes. Limacorporate S.p.A recalled REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self on 1 Oct 2021. The recall is Class II and its status is Terminated. Recall number Z-0160-2022.
Why was it 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 lots are affected?
2103825
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Limacorporate S.p.A
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate S.p.A | Sterility | Nationwide |
| Device | CLASS II | Prima Eccentrical Adaptor With Screw recalled by Limacorporate S.p.A | Limacorporate S.p.A | Sterility | Nationwide |
| Device | CLASS II | TEMA Elbow - Axle Small recalled by Limacorporate S.p.A | Limacorporate S.p.A | Other | FL, TX |
| Device | CLASS II | Prima TT Glenoid Monoblock/Modular reverse TT baseplates recalled | Limacorporate S.p.A | Lead & Heavy Metals | 6 states |
| Device | CLASS II | Physica HPS Tibial Liner #6 H10 recalled by Limacorporate S.p.A | Limacorporate S.p.A | Packaging Defects | 5 states |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |