Z-1518-2026Class II
Endo-Model Replacement Plateau; Item Number: 15-8521/09
Waldemar Link GmbH & Co. KG / initiated 2026-01-12 / Open, Classified
Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Endo-Model Replacement Plateau; Item Number: 15-8521/09 on . FDA classified it as Class II and gives the reason as "The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1518-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Waldemar Link GmbH & Co. KG
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/09;
- Product code
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Reason for recall
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- FDA 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 [email protected]. 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 in commerce
- 8 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.
- Product codes and lots
- Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1511-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1512-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1513-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1514-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1515-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1516-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1517-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1518-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1519-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1520-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1521-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1522-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1523-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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