FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model Replacement Plateau; Item Number: 15-0027/11;
- Recall number
- Z-1521-2026
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/11;
- Status
- Open, Classified
- Initiated
- 2026-01-12
- Posted
- 2026-03-10
- Terminated
- not on file
- Reason
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Root cause
- Under Investigation by firm
- Action
- On or about January 12, 2026 URGENT FIELD SAFETY NOTICE Product Recall letters were sent to customers. Actions to be taken: Review inventory to identify and quarantine any affected product. Return any unused product to the manufacturer. Follow patient management recommendations, if implanted. A custom-made replacement set can be requested. If an affected product is noticed during implantation, another plateau screw from a replacement set or different LINK knee prosthesis package can be used. If this situation occurs, a complaint form must be completed and sent to Complaint@link-ortho.com. The replacement of the affected products will begin as soon as replacement products are available. Replacement will not incur any costs to you. Should you have any questions on acquiring replacements for forthcoming surgeries, please contact your local sales representative or customer service for Link products.
- Quantity
- 2 units (OUS only)
- Distribution
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- Lot, serial or model codes
- Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;
- 510(k) numbers
- ["K151008"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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