Device recall: Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM

US nationwide distribution. Also Portugal and the Netherlands.

Zimmer Biomet, Inc., Warsaw, IN.

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

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

The table shows 60 of 65 product records. The FDA enforcement report lists all the records.

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 2017

1,091

Share of these events in Class II

93%

Product records in this event

65Median of the firm: 1

Events of the firm on the register

144

Zimmer Biomet, Inc.: all 144 events

• FDA enforcement report Z-0420-2018The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: US nationwide distribution. Also Portugal and the Netherlands.

What quantity of product is in FDA event 78763?

The event has 65 product records. The first record gives this quantity: 638 units

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2017 have the same class?

93% of the 1,091 device events that started in 2017 are in Class II.