Home › CURVAFIX, INC. › Tissue Sleeve, Removal Tool
Tissue Sleeve, Removal Tool
CURVAFIX, INC. · Model RKS-001 · UDI-DI 10855068008768
LXH
Prescription
10
510(k) clearances
82,132
Adverse events (55 deaths)
526
Recalls
1,118
Facilities
Description
A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protect the patient soft tissue. It also contains three integrated holes around the outside diameter to accept Guide Pins to maintain the sleeve position hands-free.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused |
| 2026-07-01 | Biomet, Inc. | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-03-19 | United Orthopedic Corp. | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| 2025-03-28 | Stryker GmbH | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
| 2025-03-28 | Stryker GmbH | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.