Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 151

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.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Limacorporate S.p.A under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Limacorporate S.p.A

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