The Recall Desk
HighFDA (Devices)·Z-0160-2022·Announced 2021-10-27

Bone Screw Labeling Error: Actual Length May Not Match Package Label

Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (surgical implant with potential dimension mismatch) where no injuries have been reported. Incorrect bone screw length could affect surgical fixation and implant stability. FDA classified the recall as Class II; the absence of reported injuries combined with a theoretical hazard supports a High severity rating.

Plain-English summary

Limacorporate S.p.A is recalling REF 8420.15.010 bone screws (titanium alloy Ti6Al4V, self-tapping, 6.5 mm diameter, 20 mm nominal length) distributed in boxes of 200 units. The recall involves a potential labeling discrepancy where the length printed on the package may not correspond to the actual length of the screws included.

If the actual length of a bone screw differs from the labeled length, surgeons performing orthopedic procedures may inadvertently select or install a screw of incorrect dimensions. A screw that is shorter than labeled may not provide adequate fixation, while a screw that is longer than labeled may protrude and cause tissue damage. Either scenario could compromise implant stability and affect surgical outcomes.

The recalled screws have been distributed worldwide, including in the United States to California, Florida, Missouri, Kansas, Colorado, Texas, Illinois, Pennsylvania, New York, North Carolina, Michigan, Massachusetts, and Oklahoma. International distribution includes Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden. The affected product lot is identified by code 2103825 and UDI (01)08033390018845.

Healthcare providers and patients should contact Limacorporate S.p.A or the FDA for instructions on product verification and corrective action before using any affected screws. Do not implant screws until the length discrepancy has been verified and resolved.

The recalled product

Product
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Manufacturer
Limacorporate S.p.A
Category
Medical Device — Orthopedic Implant
Hazard
  • mis-labeling
  • implant-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 2103825

Distribution

Distributed nationwide across the United States.

Related recalls

Same category