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Synthes GmbH · Model SD800.506 · UDI-DI 10887587065663
GXN
Prescription
2
510(k) clearances
824
Adverse events (2 deaths)
11
Recalls
49
Facilities
Description
PSI SD800.506 PEEK IMPLANT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
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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.