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Synthes GmbH · Model 311.048.01S · UDI-DI 10887587035802
HBG
Prescription
1
510(k) clearances
59
Adverse events
54
Recalls
57
Facilities
Description
TAP F/2.5MM RESORBABLE EMERG SCREW/(SLF-DRLG) 8MM-STERILE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Medtronic Neurosurgery | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices |
| 2024-04-17 | Integra LifeSciences Corp. | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
| 2024-01-19 | Integra LifeSciences Corp. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. |
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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.