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Open, Classified

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

FDA Recall Z-1298-2024 · Posted 2024-03-14

Recall StatusOpen, Classified
Product CodeJDG
Date Initiated2024-02-06
Product Quantity153 Units

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.

Firm Action

Urgent Medical Device Correction (UMDC) Letters were sent via email to consignees on February 16, 2024. Actions to be taken by the customer/user: Please take note of the clarification of the carton label noted in section 2. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to correctly interpret the Size and Type columns on the label. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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