FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Recall number
- Z-2934-2026
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Status
- Open, Classified
- Initiated
- 2026-07-06
- Posted
- 2026-08-11
- Terminated
- not on file
- Reason
- The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Root cause
- Process change control
- Action
- Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio.
- Quantity
- 1 US; 9 OUS
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Lot, serial or model codes
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- 510(k) numbers
- ["K143179"]
- PMA numbers
- not on file
- Product code
- KRO
- 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