Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by 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.

Recommended Action

Per FDA guidance

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