LINK SymphoKnee Patella Sizing Template, Item Number… recallZ-2445-2024 · Link Bio Corp · initiated Jun 27, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Link Bio Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2445-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 27, 2024
- Posted by the FDA
- Jul 25, 2024
- Recalling firm
- Link Bio Corp
- Quantity
- 8 units
- Product code
- HWT
- Distribution
- US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Product description
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Code information (models, lots, serial numbers)
Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LinkSymphoKnee - Instruments 881-509/00WALDEMAR LINK GmbH & Co. KG · TEMPLATE1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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