Lower riskMedical device recall · FDA · Published October 1, 2021
Limacorporate Bone Screws May Not Match Label Length - Recall
Limacorporate recalls bone screws that may not match label length. This could lead to improper use during medical procedures. Affected units have specific model numbers and were sold in the U.S. Learn how to check and what to do.
“Limacorporate Bone Screws May Not Match Label Length - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61722-limacorporate-bone-screws-may-not-match-label-length-recall. Based on FDA recall #Z-0159-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0159-2022%22&limit=1).
The FDA announced on Oct. 1, 2021, that Limacorporate S.p.A. is recalling REF 8420.15.020 bone screws because the labeled length may not match the actual screw length. The agency classified the recall as Class II.
How to tell if you have it
Brand: Limacorporate
Product: Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R
REF: 8420.15.020
Lot code: 2100099
UDI: (01)08033390018852; 2103525
UPC: 08033390018852
Units affected: 151
The hazard
According to the FDA, there is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Context
GovInfoNow's records show Limacorporate S.p.A has issued eight other recalls since Sept. 8, 2017. Recent brand recalls include a May 19, 2025 recall for PRIMA 4MM Eccentric Adaptors due to missing laser marking and an Oct. 2, 2024 recall for TEMA Elbow Prostheses regarding potential surgical risk. Other recent recalls of similar products include the XTANT Medical Xpress Pedicle Screw System (Feb. 18, 2026), the Tornier Perip Screw (Dec. 19, 2025), and the Smith & Nephew BIOSURE HA Screw (Nov. 24, 2025).
How to tell if you have this one
Check for model number REF 8420.15.020 on the packaging or label. The screws are labeled as Ti6AI4V, 6.5mm diameter, 25mm length, sterile, and have specific UDI codes.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Look for the model number REF 8420.15.020 on the packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Kansas, Massachusetts, Michigan, Missouri, New York, North Carolina, Oklahoma, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall states there is a potential that the length of the screws may not match the label, which could lead to improper use during medical procedures. However, the hazard is not described as causing serious injury in normal use.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0159-2022 (October 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0159-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.