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canturio™te Impaction Sleeve
Canary Medical USA LLC · Model 43-5399-001-14 · UDI-DI 00850015699061
QPP
Prescription
1
510(k) clearances
3
Adverse events
1
Recalls
3
Facilities
Description
The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-02 | Canary Medical, Inc. | Due to labeling error. Product incorrectly labeled. |
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