Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817
Summary
The FDA issued a Class II for Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817 by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to.
Details
Source
Device Recall
External ID
Z-1380-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Lot/Code Info: UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741
Quantity Affected: 3785
Reason for Recall
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Distribution
Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
Norderstedt
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 143 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-1380-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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