Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Compone
Summary
The FDA issued a Class II for Endo Model SL Tibial Components 16-2817/02 Tibial Component, S by Waldemar Link GmbH & Co. KG (Mfg Site). Reason: Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, pro.
Details
Source
Device Recall
External ID
Z-2411-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
Lot/Code Info: Product UDI-DI 16-2817/02 04026575359202; 16-2817/05 04026575359219; 16-2817/07 04026575359226; 16-2817/32 04026575370870; 16-2817/35 04026575370887; 16-2817/37 04026575370894. All product lots manufactured since 01-Jun-2022.
Quantity Affected: 114 units US; 2351 units OUS
Reason for Recall
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Distribution
Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-22
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 198 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-2411-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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