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Open, Classified

Embrace Drill Tower, Wedged (25mm)

FDA Recall Z-1257-2024 · Posted 2024-03-06

Recall StatusOpen, Classified
Product CodeHTW
Date Initiated2024-01-29
Product Quantity6 units

Reason for Recall

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Firm Action

LinkBio Corp issued Urgent: Medical Device Correction letter via email on 2/8/24 to Distributors. Letter states reason for recall, health risk and action to take: Please take note of the correction of the Surgical Techniques 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 follow the updated surgical technique. 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 and LA.

Official Source

View FDA Recall →

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

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