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Unicondylar Sled ProsthesisRecalls & reported problems across all models

WALDEMAR LINK GmbH & Co. KG · 48 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

48 open recalls name at least one Unicondylar Sled Prosthesis model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
12
Deaths reported
0
Injuries reported
12
Recalls
48

We found 48 models of Unicondylar Sled Prosthesis by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2019 and Mar 18, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

48 FDA recall records name at least one of these models by its device identifier, 48 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Unicondylar Sled Prosthesis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1554-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  2. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1553-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  3. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1552-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  4. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1551-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  5. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1550-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  6. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1549-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  7. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1548-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  8. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1547-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  9. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1546-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  10. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1545-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  11. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1544-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  12. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1543-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  13. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1542-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  14. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1541-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  15. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1540-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  16. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1539-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  17. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1538-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  18. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1537-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  19. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1536-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  20. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1535-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  21. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1534-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  22. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1533-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  23. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1532-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  24. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1531-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  25. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1530-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  26. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1529-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  27. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1528-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  28. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1527-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  29. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1526-2023 · Root cause: Labeling design · Recall details · FDA record ↗

  30. Mar 21, 2023Open, Classified

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Z-1525-2023 · Root cause: Labeling design · Recall details · FDA record ↗

…and 18 older recalls, listed on each model's page.

Most reported Unicondylar Sled Prosthesis problems

Device problems

  • Fracture4
  • Loosening of Implant Not Related to Bone-Ingrowth3
  • Crack2
  • Degraded2
  • Device Dislodged or Dislocated2
  • Detachment of Device or Device Component1
  • Insufficient Device Problem Information1
  • Loose or Intermittent Connection1

Patient problems

  • Failure of Implant9
  • Pain6
  • Fall1
  • Unspecified Tissue Injury1

Unicondylar Sled Prosthesis models

48 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Unicondylar Sled Prosthesis adverse event reports

The 12 most recent reports across all models, in the reporter's own words as published by the FDA.

Other WALDEMAR LINK GmbH & Co. KG products

All WALDEMAR LINK GmbH & Co. KG devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page