LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and re
Summary
The FDA issued a Class II for LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medi by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientat.
Details
Source
Device Recall
External ID
Z-2067-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Lot/Code Info: UDI-DI: 04026575257393 Lot Number: 2123233
Quantity Affected: 20 units
Reason for Recall
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Distribution
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-23
Company
Norderstedt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Waldemar Link GmbH & Co. KG (Mfg Site)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Waldemar Link GmbH & Co. KG (Mfg Site) have FDA actions?
Waldemar Link GmbH & Co. KG (Mfg Site) has 61 FDA actions in our database, including 61 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2067-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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