Z-2445-2024Class II

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

Name: Z-2445-2024 LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Creator: Link Bio Corp
Published: 2024-06-27
License: https://open.fda.gov/license/

Link Bio Corp / initiated 2024-06-27 / Open, Classified / root cause: labeling and UDI

FDA source

LINK BIO CORP began a recall of LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 on 2024-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2445-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-27
Posted: 2024-07-25
Recalling firm: Link Bio Corp
Product: LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Product code: HWT Template
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.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: On 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 [email protected] 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 commerce: 8 units
Distribution: US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Product codes and lots: Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2445-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2445-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)