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U.S. Department of Health and Human Services

Class 2 Device Recall LINK SymphoKnee Patella Sizing Template

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 Class 2 Device Recall LINK SymphoKnee Patella Sizing Templatesee related information
Date Initiated by FirmJune 27, 2024
Date PostedJuly 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2445-2024
Recall Event ID 94926
Product Classification Template - Product Code HWT
ProductLINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Code Information Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
Recalling Firm/
Manufacturer		 LINK BIO CORP
69 King St Ste 2
Dover NJ 07801-2800
For Additional Information ContactJennifer Lubrecht
862-477-0370
Manufacturer Reason
for Recall		The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
FDA Determined
Cause 2		Process change control
ActionOn June 27, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent via email to distributors. Actions to be taken by the Customer/User: Please check your inventory for this item and lot combination. If the markings are incorrect, as indicated in Section 5 below, please return the affected product to LinkBio. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return any affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned, should any affected product be identified. Please return any affected product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. 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 Commerce8 units
DistributionUS Nationwide distribution in the states of FL, GA, KS, OH, WI.
Total Product Life CycleTPLC 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.
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