The Recall Desk
HighFDA (Devices)·Z-0159-2022·Announced 2021-10-27

Orthopedic Bone Screws Recalled Due to Potential Length Mislabeling

Limacorporate S.p.A is recalling 151 units of bone screws because the labeled length may not match the actual screw length included in the package.

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 an FDA Class II medical device recall. The hazard—a potential mismatch between labeled and actual bone screw length—represents a risk-of-harm for orthopedic surgical procedures where dimensional accuracy is critical, fitting the rubric criterion for risk-of-harm products where injury has not been reported.

Plain-English summary

Limacorporate S.p.A is recalling 151 units of bone screws (model REF 8420.15.020), surgical devices used in orthopedic procedures. The manufacturer identified a potential discrepancy: the length specified on the product labeling may not match the actual length of the included screws.

The affected screws were distributed worldwide. In the United States, distribution occurred in California, Colorado, Florida, Illinois, Kansas, Massachusetts, Michigan, Missouri, New York, North Carolina, Oklahoma, Pennsylvania, and Texas. Internationally, the product was distributed to Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.

Healthcare providers and facilities with affected inventory should identify the products using manufacturer code 2103525 and the unique device identifier listed on the labeling. Limacorporate S.p.A should be contacted for guidance on product replacement or corrective actions.

The recalled product

Product
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Manufacturer
Limacorporate S.p.A
Category
Medical Device — Orthopedic / Surgical Hardware
Hazard
  • mislabeling
  • device-length-discrepancy

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)

  • 2103525

Distribution

Distributed nationwide across the United States.

Related recalls

Same category