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Integra® NuGrip®
Ascension Orthopedics, Inc. · Model TRL44330M · UDI-DI 10381780236559
KYI
Prescription
1
510(k) clearances
346
Adverse events
5
Recalls
22
Facilities
Description
The NuGrip Trial is used to evaluate the size and fit of the implant.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2013-06-03 | Integra LifeSciences Corp. | As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2003-01-24 | Avanta Orthopaedics, Inc. | Wrong silicone elastomer used in construction. |
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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.