Device recall: Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005

US Nationwide. Australia, Canada, Japan, Korea, Singapore.

Stryker Corporation, Portage, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Device events that started in 2023

917

Share of these events in Class II

88%

Product records in this event

19Median of the firm: 2

Events of the firm on the register

37

Stryker Corporation: all 37 events

• FDA enforcement report Z-0239-2024The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: US Nationwide. Australia, Canada, Japan, Korea, Singapore.

What quantity of product is in FDA event 93211?

The event has 19 product records. The first record gives this quantity: 2,321 total units

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2023 have the same class?

88% of the 917 device events that started in 2023 are in Class II.