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gSource
GSOURCE LLC · Model gS 51.5452 · UDI-DI 00840314224965
10
510(k) clearances
71
Adverse events (1 deaths)
3
Recalls
219
Facilities
Description
Cobb Curette 11" alum str #2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2013-11-05 | Zimmer, Inc. | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged pr |
| 2011-07-15 | X Spine Systems Inc | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque i |
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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.