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Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231

by Codman & Shurtleff, Inc. 510(k)

Active United States Open recall

510(k) K073336

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK073336 Date4 Jan 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1717-2025 FDA Class I initiated 11 Apr 2025

    Inadequate weld that can potentially cause the product to disassemble.

Specification

510(k)

510(k) Number
FDA Product Code
HBF
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 882.4305
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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