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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Screws 6.5mm

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  Class 2 Device Recall Bone Screws 6.5mm see related information
Date Initiated by Firm October 01, 2021
Create Date October 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-0160-2022
Recall Event ID 88812
510(K)Number K172456  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Code Information 2103825
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information Contact Roberto Gabetta
+390432945511
Manufacturer Reason
for Recall		 There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = LimaCorporate S.p.A.
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