Recall Z-1257-2024 ยท HTW Bit, Drill
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Wedged (25mm)
| Date | Mar 6, 2024 (initiated Jan 29, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 complaints@linkbio.com for any questions. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the states of AL and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.