SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Reported: March 20, 2024 Initiated: February 6, 2024 #Z-1298-2024
Product Description
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Reason for Recall
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Units Affected
- 153 Units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
- Location
- Norderstedt, N/A
Frequently Asked Questions
What product was recalled? ▼
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 153 Units.
Why was this product recalled? ▼
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1298-2024.
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