FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Embrace Drill Tower, Standard/Lateral (25mm)
- Recall number
- Z-1258-2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Embrace Drill Tower, Standard/Lateral (25mm)
- Status
- Open, Classified
- Initiated
- 2024-01-29
- Posted
- 2024-03-06
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
- 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