Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compon
FDA device recall Z-0890-2026 · posted 2025-12-09 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
- Action taken
- On November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KRO
- Quantity affected
- 18 units
- Distribution
- US distribution to states of: AL, GA, and TX.
- Date initiated
- 2025-11-10
- Date posted
- 2025-12-09
- Location
- Norderstedt, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINK® MEGASYSTEM-C® (K151008) | Waldemar Link GmbH & Co. KG | 2015-08-26 |