FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- Recall number
- Z-1651-2026
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- Status
- Open, Classified
- Initiated
- 2026-02-11
- Posted
- 2026-03-27
- Terminated
- not on file
- 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
- 75 units
- Distribution
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Lot, serial or model codes
- Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3003386935
- Firm city
- Norderstedt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28