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Hayden Medical

Hayden Medical, Inc. · Model 040-358/2 · UDI-DI 00840319718209

FZS Prescription
10
510(k) clearances
71
Adverse events (1 deaths)
3
Recalls
219
Facilities

Description

Curette with Hole 5-1/2" (13.8cm), large, 2mm diameter

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2013-11-05Zimmer, 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
2011-07-15X Spine Systems IncThe 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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Data 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.