Recall Z-1652-2026 ยท HTW Bit, Drill
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
| Date | Mar 27, 2026 (initiated Feb 11, 2026) |
| Status | Open, Classified |
| Reason | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. |
| Root cause | Under Investigation by firm |
| Action | On February 11, 2026 "URGENT: MEDICAL DEVICE CORRECTION" letters were emailed to customers. Actions to be taken: Please take note of the correction of the Surgical Technique 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 | 74 units |
| Distribution | US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.