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ExactechGPS Total Shoulder Application

by Blue Ortho 510(k)

Active United States Open recall

510(k) K173372

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 NumberK173372 Date24 Nov 2017ClearedStatusActive

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  • Withdrawn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-2050-2023 FDA Class II initiated 5 Jun 2023

    The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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