Z-2048-2023 Class II Ongoing
FDA device recall Z-2048-2023 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on March 18, 2021 and is designated Class II. Reason for recall: The firm discovered through customer complaints that device segments may not meet specifications. The recall status is ongoing. Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- March 18, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
Reason for Recall
The firm discovered through customer complaints that device segments may not meet specifications.
Distribution Pattern
Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Code Information
Item No. 15-2979/01; UDI-DI: 04026575328093.