FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
- Recall number
- Z-0160-2022
- Recalling firm
- Limacorporate S.p.A
- Product
- REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
- Status
- Terminated
- Initiated
- 2021-10-01
- Posted
- not on file
- Terminated
- 2024-06-27
- Reason
- There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
- Root cause
- Mixed-up of materials/components
- Action
- On October 1, 2021 , Lima Corporate issued an "Urgent: Medical Device Recall" notification to all affected consignees via email. In addition to informing consignees about the recall product, the firm asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices received. Affected devices are required to be sent back to LimaCorporate together with a hard copy of the attached Response Form; 2. Fill out, sign and send the attached Response Form to the email address pms@limacorporate.com, as a confirmation that You have read and acknowledged the content of this Field Safety Notice; 3. If the product was further distributed, please provide those customers with a copy of this customer notification and response form. Once completed, please forward the response form to pms@limacorporate.com. 4. If needed, please address any inquiry on this Field Safety Notice (FSN) to the email address medicalcomplaints@limacorporate.com. 5. This notice needs to be passed on all those who need to b. e aware within your organization. This Field Safety Notice will be sent to the Competent Authorities of the Countries involved in this Field Safety Corrective Action. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax
- Quantity
- 200 units
- 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.
- Lot, serial or model codes
- 2103825
- 510(k) numbers
- ["K172456"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28