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MaxMoreSpine

Hoogland Spine Products GmbH · Model 1001-ABR 8 · UDI-DI 04260200313751

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

Description

Reverse Curette, 3.0mm

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.