Embrace Drill Tower, Standard/Lateral (25mm)
- Recall Initiated
- January 29, 2024
- Posted
- March 6, 2024
- Recall Number
- Z-1258-2024
- Quantity
- 6 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.
Distribution
US Nationwide distribution in the states of AL and LA.
Lot / Code Info
Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
Root Cause
Under Investigation by firm
Action Taken
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 complaints@linkbio.com for any questions.