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GMK Sphere Cementless
Medacta International SA · Model 02.12.1504R · UDI-DI 07630345799081
MBH
Prescription
1
510(k) clearances
16,331
Adverse events (11 deaths)
102
Recalls
217
Facilities
Description
GMK Sphere Femur Porous TiGrowthC+HA S4R
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-19 | Howmedica Osteonics Corp. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon |
| 2026-05-19 | Howmedica Osteonics Corp. | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon |
| 2026-05-11 | Zimmer, Inc. | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. |
| 2024-10-29 | MicroPort Orthopedics Inc. | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging. |
| 2024-03-13 | Biomet, Inc. | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. |
| 2024-03-12 | DePuy Orthopaedics, Inc. | Product incorrectly labelled. |
| 2024-02-06 | Howmedica Osteonics Corp. | Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 | Howmedica Osteonics Corp. | Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 | Howmedica Osteonics Corp. | Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 | Howmedica Osteonics Corp. | Potential packaging breaches of inner blister and outer sterile blister. |
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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.