Recall Z-1474-2023— Stryker Corporation

Name: FDA recall Z-1474-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-02

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2023-03-02. It names one FDA 510(k) clearance: K082813. Product: SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200. Reason: Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-03-02
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082813 — STRYKER LED LIGHTSOURCEStryker Corp.·cleared 2008-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

Reason for recall

Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.

Data sourced from openFDA. This site is unofficial and independent of the FDA.